Search Results (190)

The optimal revascularization strategy for common femoral artery (CFA) atherosclerotic occlusive disease remains debated. This systematic review and meta-analysis compared perioperative and long-term outcomes of endovascular therapy (EVT) and open surgery (OS). Methods: PubMed, Embase, Web of Science, the Cochrane Library, and ClinicalTrials.gov were searched through 15 March 2026 for comparative studies of EVT versus OS in CFA atherosclerotic occlusive disease. Outcomes included perioperative morbidity, wound complications, hospital stay, patency, reintervention, major amputation, and survival. Time-to-event data were pooled as hazard ratios (HRs), reported or reconstructed from Kaplan-Meier curves. Risk of bias and evidence certainty were assessed. Results: Eleven studies with 2835 patients were included. Compared with OS, EVT reduced 30-day morbidity (OR, 0.34; 95% CI: 0.26–0.44), wound complications (OR, 0.14; 95% CI: 0.09–0.23), surgical-site infections, lymphatic complications, myocardial infarction, and hospital stay (mean difference, −4.68 days; 95% CI: −5.49 to −3.86). Distal embolization increased after EVT (OR, 2.45; 95% CI: 1.28–4.70). Follow-up major amputation was higher after EVT in event-rate analyses (OR, 2.42; 95% CI: 1.19–4.93), although amputation-free survival was similar (HR, 1.01; 95% CI: 0.83–1.23). EVT had higher hazards of loss of primary patency (HR, 1.72), loss of secondary patency (HR, 2.03), and reintervention (HR, 1.51). Conclusions: EVT offers fewer early complications and shorter hospitalization, whereas OS provides more durable patency and fewer reinterventions. Given observational, heterogeneous evidence, treatment should be individualized. Full article

Background: Intraoperative vascular injuries during elective hip and knee arthroplasty are uncommon but limb-threatening complications. Real-world evidence on emergency on-call vascular management in this setting remains limited. We aimed to identify the intraoperative ischemia time threshold associated with progression to a more severe ischemic presentation (Rutherford IIb) at vascular consultation, in order to support early multidisciplinary activation and prevent irreversible ischemic limb damage. As a secondary aim, we described the clinical spectrum, treatment strategies, and 30-day outcomes of patients managed by a 24 h on-call vascular service (in-hospital coverage during working hours, formal on-call rota out of hours). Non-ischaemic events recorded in the series (e.g., isolated venous injuries and haemorrhagic complications) are documented as part of the overall clinical spectrum but were not the subject of specific time-related analysis. Methods: Single-centre retrospective analysis of 33 consecutive patients undergoing emergency vascular intervention for vascular injury during elective total knee (TKA) or total hip arthroplasty (THA) at a tertiary orthopaedic referral centre in Milan, Italy (January 2023—December 2025). The primary analytical objective was to identify the intraoperative ischemia time threshold associated with Rutherford IIb presentation at vascular consultation; 30-day limb salvage was the primary clinical outcome. Secondary outcomes included technical success, primary 30-day patency, postoperative ankle–brachial index (ABI), length of stay, and Clavien–Dindo complications. Non-ischaemic events (including isolated venous injuries and haemorrhagic complications) are documented as part of the clinical spectrum but were not subject to specific time-related analysis. Receiver operating characteristic (ROC) analysis assessed the discriminative role of intraoperative ischemia time for a Rutherford IIb presentation; univariate logistic regression explored predictors of postoperative complications. Results: Thirty-three patients (mean age 76.3 ± 6.3 years; 54.5% female; ≥2 comorbidities in 81.8%) underwent emergency vascular repair after TKA (60.6%) or THA (39.4%). Injuries were mixed arteriovenous (54.5%), purely venous (24.2%), or purely arterial (21.2%). Mean call-to-incision time was 45.4 ± 11.3 min. In the 25 ischemic cases, the mean intraoperative ischemia time was 130.4 ± 18.7 min. ROC analysis identified an optimal cut-off of 131 min for Rutherford IIb (AUC 0.851, 95% CI 0.679–0.982; p < 0.001), with sensitivity 81.8% and specificity 85.7%. Median ischemia time was significantly higher in IIb than IIa cases (144 vs. 124.5 min; p = 0.003). Technical success and 30-day limb salvage were 100% (95% CI 89.6–100); mean postoperative ABI 0.89 ± 0.03; primary 30-day patency 88.0% (95% CI 70.0–95.8), with secondary patency 100%. All postoperative complications were Clavien–Dindo grade 1; no Clavien–Dindo ≥ 2 events and no 30-day mortality were observed. Conclusions: A dedicated 24 h on-call vascular service achieves excellent 30-day limb salvage and patency in iatrogenic vascular injuries occurring during arthroplasty. An intraoperative ischemia threshold of 131 min identifies higher-risk presentations and supports rapid multidisciplinary activation in high-volume orthopaedic centres. Full article

The rising prevalence of chronic kidney disease represents a major global health burden. Limitations of current renal replacement therapies, including donor organ shortages, rejection, and dialysis-related complications, underscore the need for innovative treatment options. This narrative review assesses the feasibility of bioengineered kidneys as an alternative to current treatments by discussing advances in decellularization, recellularization, and the transplantation of cell-on-scaffold kidneys. We propose that the development of functional bioengineered kidneys follows a hierarchical, staged process, in which vascular patency is the primary prerequisite for graft survival, followed by partial restoration of glomerular filtration, with complete tubular function remaining the final and most challenging milestone. Perfusion-based whole-organ decellularization has made significant progress in preserving the extracellular matrix, enabling the production of acellular human kidney scaffolds. However, complete recellularization of whole kidneys has not yet been achieved. Nevertheless, partially repopulated kidney scaffolds have been shown to withstand physiological blood pressure, produce urine, and exhibit filtration in large-animal models. Complete endothelial coverage of the vascular network proved essential for preventing thrombosis after transplantation. Current work on bioengineered kidneys shows promising results regarding feasibility for clinical application. It is important to note that most of the included studies are proof-of-concept, characterized by small sample sizes and short observation periods. Although these findings are crucial for further research, they cannot be generalized, and larger trials are recommended. In addition to cell-on-scaffold kidneys, 3D bioprinting is a promising technique that could eliminate the need for donor scaffolds. Full article

Background: The objective was to synthesize and critically appraise systematic reviews with meta-analysis evaluating the association between irrigation, instrumentation, and obturation procedures and post-operative endodontic pain. Methods: An umbrella review was conducted following PRISMA guidelines. Electronic searches identified systematic reviews published between 2016 and 2025. Eligible studies are systematic reviews that include meta-analyses, published in English and correlating the presence of post-operative pain in 3 different critical stages of root canal treatments, namely irrigation, instrumentation and obturation. Methodological quality was assessed using the AMSTAR 2 tool. Outcomes included pain prevalence and intensity at different time points. Results: Out of 368 records, 25 systematic reviews with meta-analysis met the inclusion criteria: 9 on irrigation, 8 on instrumentation, and 8 on obturation. NaOCl concentrations, irrigant activation, and intracanal cryotherapy were repeatedly reported as being associated with reduced short-term post-operative pain. For instrumentation, most reviews reported lower pain with rotary systems, but two studies found no difference or favored reciprocating kinematics. Apical patency did not appear to increase pain and foraminal enlargement may increase early pain. No clinically consistent differences were observed between bioceramic/calcium silicate-based and resin-based sealers, although calcium silicate sealers seem to support periapical healing. However, the certainty of these findings was limited by heterogeneity, methodological weaknesses, and overlap among primary studies. Methodological limitations were identified across reviews, mainly related to no protocol registration (n = 4), incomplete reporting of excluded studies with justification (n = 11), limited assessment of publication bias, and poor reporting of funding sources for primary studies. Conclusions: Based on current evidence, irrigation, instrumentation, and obturation procedures may influence short-term post-operative pain. However, these findings remain tentative because of heterogeneity, methodological weaknesses, variable review quality, and overlap among primary studies. Further high-quality reviews and clinical trials are needed. Full article

Background: While recent literature emphasizes the predictive value of composite inflammatory and nutritional indices for vascular outcomes, this study evaluates the actual predictive capacity of preoperative indices (PNI, GNRI, SII, NLR, PLR) for de novo arteriovenous fistula (AVF) maturation and 1-year primary patency. Methods: We retrospectively analyzed 945 end-stage renal disease patients who underwent strictly radio-cephalic autologous AVF creation. Preoperative indices were calculated from routine parameters. Diagnostic accuracy for predicting 1-year patency loss was assessed using receiver operating characteristic (ROC) curves, and a multivariate logistic regression model was constructed to adjust for baseline anatomical and clinical variables. Targeted subgroup analyses evaluated high-risk populations, including those with diabetes, coronary, and peripheral artery disease. Results: The 1-year primary and secondary patency rates were 73.3% and 93.1%, respectively. In contrast to prevalent reports, no significant differences in preoperative PNI, GNRI, NLR, PLR, or SII scores existed between patients with patent and thrombosed fistulas (p > 0.05). ROC analyses showed no predictive utility (AUC: 0.476–0.518). Crucially, multivariate logistic regression revealed that preoperative arterial (OR: 0.58, p < 0.001) and venous diameters (OR: 0.51, p < 0.001) were the strongest independent predictors of AVF failure, whereas all systemic biomarkers lacked independent predictive significance. Subgroup analyses confirmed these indices failed to predict AVF outcomes even in high-risk settings with severe endothelial dysfunction. Conclusions: Preoperative composite nutritional and inflammatory indices do not independently predict AVF maturation or long-term patency when adjusted for local anatomy. Local anatomical features and hemodynamics heavily dominate vascular outcomes, indicating that systemic biomarkers have limited standalone clinical utility for guiding preoperative vascular access planning. Full article

Background/Objectives: Early thrombosis of systemic-to-pulmonary artery shunts (SPS) remains a major cause of morbidity and mortality in neonates with duct-dependent pulmonary circulation. Despite advances in surgical technique, no universally accepted perioperative thrombosis-prevention protocol exists. We evaluated the early outcomes of a standardized perioperative thrombosis-prevention protocol applied in neonates undergoing SPS placement. Methods: This single-center case series included nine consecutive neonates undergoing primary modified Blalock–Taussig shunt placement between January 2024 and July 2025. A predefined and standardized perioperative thrombosis-prevention protocol was uniformly applied, incorporating preoperative aspirin when feasible, intraoperative systemic heparinization targeting activated clotting time (ACT) > 300 s, meticulous shunt flushing and de-airing, preferential distal anastomosis to the main pulmonary artery when anatomically suitable, and early postoperative continuous heparin infusion followed by enteral aspirin. The primary endpoint was early shunt thrombosis within 30 days. Results: Median age at surgery was 28 days (range 14–35), and median operative weight was 3.2 kg (range 2.8–3.6). Cardiopulmonary bypass was required in 33.3% of patients. Delayed sternal closure was performed in 22.2%. Despite recognized prothrombotic risk factors—including complex anatomy, hypoplastic pulmonary arteries, and low cardiac output syndrome (33.3%)—no early shunt thrombosis occurred (0/9). There were no reinterventions, no early mortality, and no major bleeding or intracranial hemorrhage. Conclusions: In this single-center neonatal series, implementation of a standardized perioperative thrombosis-prevention protocol was associated with preserved early shunt patency without increased bleeding risk. Although limited by a small sample size, these findings support the feasibility and short-term safety of a standardized perioperative management strategy in neonatal systemic-to-pulmonary shunt surgery. These findings should be considered hypothesis-generating and not evidence of definitive effectiveness. Full article

Background/Objectives: the study aims to evaluate early outcomes of endovascular aneurysm repair (EVAR) using the ultra-low-profile Minos^TM Abdominal Aortic Stent-Graft in elective and emergent infrarenal abdominal aortic aneurysm (AAA), and compare its performance with established EVAR devices. Methods: This retrospective single-centre study included 79 patients treated with the Minos stent-graft between September 2020 and August 2024. Primary endpoints were 30-day mortality and major adverse events (MAEs). Secondary outcomes included technical success, endoleak rates, sac dynamics, reintervention rates, and stent-graft patency. Imaging follow-up was performed on day 1, at 4–6 weeks, at 6–12 months, and annually thereafter. Results: The cohort (mean age 74.6 ± 8.2 years; 83.5% male) included 60 elective and 19 emergent cases, with high cardiovascular comorbidity and challenging anatomy (48.1% with iliac diameters < 7 mm and 16.5% < 5 mm; 20.3% hostile necks). Technical success rate was 93.7% (elective: 95.0%; emergent: 89.5%). Persistent endoleaks occurred in 14.0% of patients (type II 12.7%, type I 1.3%). Clinical success was achieved in 88.6% (elective: 90.0%; emergent: 84.2%). Six-month survival was 96.1% in the elective and 89.5% in the emergent cohort. MAEs were more frequent in emergent cases: acute kidney failure (31.6% vs. 3.3%; p = 0.004) and pneumonia (31.6% vs. 0.0%; p < 0.001). Mean follow-up was 12.5 ± 9.9 months (median 9.3). Reinterventions were required in 16.5% within 30 days, more frequently in emergent cases (31.6% vs. 11.7%, p = 0.041). Sac regression ≥5 mm occurred in 43.0%. No stent-graft migrations or infections were reported. Conclusions: Minos demonstrated reliable performance and safety in elective and emergent EVAR with excellent anatomical applicability due to its ultra-low-profile design. Full article

Background and Objectives: Robotic-assisted tubal reanastomosis (RATR) remains a clinically relevant option for selected women seeking fertility after sterilization. In the era of IVF, surgical reversal continues to be discussed because it may restore the possibility of spontaneous conception rather than offering only cycle-dependent treatment. However, the available evidence on RATR is heterogeneous and derives predominantly from observational studies. The aim of this narrative review with a structured literature search was to synthesize the published evidence on the operative, reproductive, and economic outcomes of RATR and to contextualize its role in contemporary fertility counseling. Materials and Methods: A structured literature search of PubMed/MEDLINE, Scopus, and Google Scholar was performed from database inception to 20 December 2025. Data were synthesized descriptively without meta-analysis. Primary robotic clinical studies were interpreted separately from secondary and contextual publications. Results: In total, 16 studies were included in our study. The evidence base comprised predominantly retrospective cohorts and case series; no randomized controlled trials were identified. Reported tubal patency endpoints in robotic cohorts ranged from 81.0% to 94.1%, although denominators differed across studies and were reported either per patient or per tube. Reported pregnancy outcomes ranged from 25% to 80%, reflecting substantial heterogeneity in patient selection, follow-up duration, and outcome definitions. When woman-level delivery or live-birth outcomes were explicitly reported, they were generally encouraging in selected series, although not uniformly defined. Estimated blood loss was usually minimal when reported, and conversion to laparotomy was uncommon. Any comparison with IVF was indirect because no contemporary head-to-head comparative studies were identified. Economic data were sparse, institution-specific, and methodologically heterogeneous. Conclusions: Available observational evidence suggests that RATR is a feasible minimally invasive option for fertility restoration in carefully selected women after sterilization. However, the evidence base remains limited by retrospective design, small cohorts, heterogeneous outcome reporting, variable follow-up, and indirect comparison with IVF. RATR should be considered within individualized fertility counseling rather than as a universal alternative to IVF. Prospective comparative studies with standardized outcome definitions, transparent reporting of prognostic factors, and robust economic evaluation are needed. Full article

Objective: To evaluate the feasibility and early outcomes of a curvature-guided strategy that guides dual-branch revascularization during Zone 1 Thoracic Endovascular Aortic Repair (TEVAR) based on whether the aortic pathology is predominantly located on the greater or lesser curvature of the arch. Methods: In this retrospective, descriptive study (February 2023–June 2024), 43 consecutive patients were included under a predefined anatomical protocol. Of these, 3 patients (7.0%) were lost to follow-up and were included in the analysis of baseline characteristics and perioperative outcomes. The remaining 40 patients constituted the per-protocol follow-up cohort. Pathologies predominantly on the aortic arch’s greater curvature (n = 21) were managed with a Castor single-branched stent-graft for the left subclavian artery (LSA) and a left common carotid artery (LCCA) chimney stent. Those on the lesser curvature (n = 22) received a physician-modified endograft (PMEG). The primary outcome was technical success; secondary outcomes included safety, branch patency, and reintervention. Results: The overall technical success rate was 97.7% (100% in the Castor-chimney cohort [21/21] vs. 95.5% in the PMEG cohort [21/22]). No perioperative stroke, spinal cord ischemia, or retrograde type A dissection occurred in either cohort. Two type II endoleaks were observed: one intraoperative in the Castor-chimney cohort and one during follow-up in the PMEG cohort. Among the 40 patients (20 per cohort) who completed a median follow-up of 22.5 months, freedom from aortic-related reintervention was 95% (38/40), with one reintervention occurring in each cohort. Branch patency was 100% (20/20) in the PMEG cohort, whereas it was 95% (one asymptomatic LSA occlusion) in the Castor-chimney cohort. Conclusions: The implementation of a curvature-guided protocol, which rationally matches endograft techniques to arch anatomy, suggests acceptable early safety and efficacy for complex Zone 1 TEVAR. This anatomy-driven framework offers a potential personalized approach to dual-branch revascularization and warrants prospective validation. Full article

Background/Objectives: The autologous arteriovenous fistula (AVF) is the primary vascular access (VA) method for hemodialysis (HD), with superior patency and a lower complication rate than arteriovenous graft (AVG) or central venous catheter (CVC). The primary objective of this study is to analyze the impact of dialysis on the CVC at the time of AVF creation on its long-term primary patency. Methods: This retrospective, single-center, observational study included 248 patients admitted for AVF creation. Demographic characteristics, comorbid conditions, and laboratory parameters were retrieved from the hospital’s electronic medical records. The primary outcome of the study was long-term AVF failure, defined as the inability to perform hemodialysis through the newly created AVF. Results: A total of 132 (53.2%) were receiving dialysis via a CVC at the time of AVF creation. During a mean follow-up of 2.21 ± 1.54 years, 47 patients (18.95%) failed to achieve functional maturation at 6 weeks, and 81 patients (32.66%) developed long-term AVF failure. Demographic characteristics were similar between patients with and without CVC at AVF creation, with no significant differences in age (p = 0.358) or sex (p = 0.574). Comorbidities and risk factors were also similarly distributed, showing no significant variation. The types of AVF varied by CVC status, with fewer RC-AVF (p = 0.038) and more BC-AVF (p = 0.032) in patients with a CVC. Failure was significantly more frequent in patients with CVC use at the time of AVF creation than in those without CVC (p < 0.001). Kaplan–Meier analysis demonstrated lower long-term patency in patients dialyzed via CVC (p < 0.001). In Cox regression analysis, dialysis via CVC at AVF creation was associated with AVF failure (HR: 2.53, p < 0.001), and the association remained significant after full adjustment (HR: 3.13, p < 0.001). Female sex, active smoking, smaller arterial and venous diameters, and RC-AVF were additional risk factors associated with failure. Conclusions: Dialysis via a CVC at the time of AVF creation was associated with an increased risk of long-term AVF failure, even after full adjustment models. Full article

The aim of this study is to determine the optimal functional size of laser peripheral iridotomy (LPI) for anterior chamber parameter improvement in primary angle-closure disease (PACD). This study evaluated 109 eyes from 62 consecutive phakic patients. Baseline and one-week post-LPI anterior segment OCT were utilized to measure anterior chamber volume (ACV), anterior chamber angle (ACA), and iridotomy dimensions. Data was analyzed using linear mixed-effects models (LMMs), generalized additive models (GAMs), and receiver operating characteristic (ROC) curves. Post-LPI, significant increases occurred in ACA 500 (+7.54°), ACV (+11.09 mm³), and gonioscopic grade. LMMs confirmed a positive association between iridotomy size and anatomical expansion. GAMs demonstrated a saturation effect for ACV improvement, plateauing at 0.1 mm² (narrow area) and 0.25–0.30 mm² (superficial area), while the ACA relationship remained predominantly linear. ROC analysis identified preliminary superficial area cutoffs of 0.14 mm² and 0.12 mm² as discriminators of above-median volumetric and angular response, respectively. These findings suggest that LPI size is an independent determinant of anatomical response, beyond simple patency. As a preliminary, hypothesis-generating target, a superficial iridotomy area of approximately 0.12–0.14 mm² was associated with above-median volumetric and angular response in this cohort. Prospective validation is required before these thresholds can be incorporated into clinical practice. Full article

Background: The primary goal of root canal treatment is the prevention and healing of apical periodontitis through the meticulous elimination of pathogenic bacteria and infected tissues. Within this framework, apical patency remains a fundamental yet debated clinical concept. Objectives: This review aims to evaluate the clinical significance of maintaining apical patency, its influence on postoperative discomfort, and the technical strategies required for predictable negotiation. Methods: We performed a comprehensive review of existing literature, including clinical studies and recent meta-analyses, focusing on the correlation between patency maneuvers and postoperative pain, the role of preoperative CBCT imaging, and the efficacy of specialized negotiation instruments and motor kinematics. While patency facilitates thorough debridement, evidence regarding its impact on postoperative pain is conflicting, with recent meta-analyses suggesting it may actually alleviate discomfort intensity. Preoperative CBCT was identified as essential for identifying complex anatomy, such as the MB2 canal. Furthermore, the use of specialized files and reciprocating motor modes enhances the predictability of glide path establishment. Conclusions: Although failure to achieve patency does not always dictate a negative outcome, it is associated with improved long-term healing. Clinicians should prioritize “Anatomical Patency”—respecting original morphology—over forceful “Operative Patency” to ensure procedural integrity and clinical success. Full article

Background/Objectives: Accurate evaluation of fallopian tube patency is an essential step in infertility assessment. This study investigated the diagnostic capability of saline infusion sonography combined with color Doppler flow (SIS-CF), using laparoscopic chromopertubation as the comparator method. Methods: A prospective diagnostic accuracy study was conducted between January and November 2025 at the Infertility Unit, Chiang Mai University Hospital, Thailand. Women requiring laparoscopic assessment for infertility evaluation or preconception investigation were consecutively enrolled. Each participant underwent SIS-CF immediately before laparoscopic chromopertubation within the same operative session. Primary outcomes included diagnostic indices for tubal patency. Secondary outcomes included procedural duration and perioperative safety. Results: Forty-four women (88 fallopian tubes) were included. SIS-CF demonstrated sensitivity of 89.4% (95% CI 78.1–95.9) and specificity of 95.5% (95% CI 77.2–99.9). Positive and negative predictive values were 98.3% and 75.0%, respectively. Likelihood ratios were 19.65 (positive) and 0.11 (negative), with overall accuracy of 90.9% (95% CI 82.9–95.8). Median procedure duration was 5.7 min for SIS-CF and 3.0 min for laparoscopic chromopertubation. No adverse events were recorded. Conclusions: SIS-CF demonstrated favorable diagnostic characteristics for evaluation of tubal patency. The technique provided functional information regarding tubal status while maintaining a minimally invasive profile. Further investigation is warranted to determine its role within routine infertility workups. Full article

Background: To evaluate the real-world safety and mid-term clinical performance of the Ankura™ AAA Stent Graft System in patients undergoing endovascular aneurysm repair (EVAR). Materials and Methods: This prospective, multicenter PMCF study analyzed 100 patients with abdominal aortic aneurysms (AAAs). Patients were monitored for a mean duration of 2.26 years. Primary endpoints included 30-day major adverse events and 24-month treatment success. Statistical evaluation of risk factors for reintervention was performed using univariate logistic regression. Results: The study cohort was predominantly male (97%), with a mean age of 72.01 years. Hypertension (90%) and smoking (89%) were the most prevalent comorbidities. Regarding the primary endpoints, the 30-day MAE rate was 2%. During the overall follow-up (mean 2.26 years), the primary patency rate was 97%, demonstrating high structural integrity and sustained patency. However, the overall freedom from reintervention rate was 74%, corresponding to a 26% reintervention requirement and a 27% incidence of endoleak. Reinterventions were almost exclusively driven by these post-procedural morphological complications; specifically, 26 of the 27 patients with endoleaks required a secondary procedure. No preoperative clinical or anatomical parameters were identified as significant independent predictors of reintervention in the univariate analysis (p > 0.05). The overall mortality rate was 12%, with 0% aneurysm-related mortality. Conclusions: Mid-term success and reintervention after EVAR with the Ankura™ system are primarily driven by postoperative morphological complications, such as endoleaks, rather than baseline patient risk profiles. These findings underscore the critical importance of rigorous, lifelong radiological surveillance regardless of preoperative anatomical challenges. Full article

Background: Intravascular lithotripsy (IVL) has emerged as a novel vessel preparation device for patients with peripheral artery disease undergoing angioplasty. The IVL catheter includes an integrated balloon, which emits high pressure and transient sonic waves. The release of shockwaves results in cracking of intimal and medial calcium within the vessel wall improving lumen patency. Objectives: The aim of this prospective observational cohort study is to evaluate the morphological and imaging changes in atherosclerotic plaque in patients with PAD undergoing IVL as a vessel preparation technique, followed by angioplasty with drug-coated balloon (DCB) or stent placement if required. Secondary endpoint is to evaluate the efficacy of IVL in the perfusion of the lower extremities, by calculating the ankle–brachial index (ABI) and toe–brachial index (TBI) post-angioplasty, as well as adverse events within 30 days. Methods: Consecutive adult (≥18 years of age) patients with symptomatic femoropopliteal artery disease selected to undergo IVL will be included in the study. Computed tomography angiography (CTA) of the lower limbs will be performed pre- and postoperatively. Intraoperatively, an intravascular ultrasound (IVUS) will be used before and immediately post-angioplasty, for real-time evaluation of the morphological and quantitative changes in the atherosclerotic plaque. All participants will be clinically re-evaluated in 30 days postoperatively and a color Duplex ultrasound of the lower extremity arteries will be performed. The perfusion of the peripheral arteries will be assessed using ABI and TBI post-procedurally. Outcomes: The primary outcome is the quantitative assessment of changes in plaque morphology and volume within the index target lesion, based on pre- and post-procedural computed tomography angiography using TeraRecon™ (Durham, NC, USA) plaque analysis module, reflecting plaque modification and redistribution, in the context of IVL-based vessel preparation. Secondary outcomes include improvement of peripheral arterial perfusion and freedom from clinically driven target lesion revascularization (CD-TLR) and major adverse events. Full article