BACKGROUND:Patients with femoropopliteal (FP) chronic total occlusions (CTOs) presenting with intermittent claudication (IC) and chronic limb threatening ischemia (CLTI) differ in disease severity and lesion complexity. We performed a subgroup analysis of the prospective, multicenter RESTOR-1 trial to evaluate the safety and effectiveness of the Santreva™-ATK Endovascular Revascularization Catheter in these patient populations. OBJECTIVES:Compare procedural and short-term clinical course outcomes of the Santreva™-ATK catheter in patients with IC and CLTI enrolled in RESTOR-1 pivotal trial. METHODS:74 patients with Rutherford class (RC) 2-5 peripheral artery disease and de novo FP CTOs were stratified into IC (RC 2-3, n=48) and CLTI (RC 4-5, n=26). The primary endpoint was clinical success, defined as successful device-facilitated guidewire placement into the distal true lumen without device-related major adverse events (MAEs). Secondary endpoints included procedural success, intravascular (IVUS)-determined crossing trajectory, and 30-day clinical outcomes. RESULTS:Clinical success was achieved in 89.6% of patients with IC and 84.6% of patients with CLTI, with similarly high technical and procedural success rates between groups. IVUS evaluation was performed in 85.4% (41/48) of patients with IC and 76.9% (20/26) of patients with CLTI. Among patients with documented crossing trajectory, 86.9% (53/61) demonstrated intraplaque crossing and 13.1% (8/61) demonstrated extraplaque crossing. Although patients with CLTI had a numerically higher prevalence of diabetes mellitus and heavily calcified lesions, these differences were not statistically significant, and crossing performance remained comparable between groups. CONCLUSION:Santreva™-ATK catheter demonstrated high clinical success and an excellent safety profile across the spectrum of FP CTO disease, supporting its use in both IC and CLTI patients.

Data on recanalization of femoropopliteal (FP) chronic total occlusions (CTOs) and characterization of the traversed crossing track are limited. The AngioSafe Peripheral-2 CTO Crossing Catheter (Santreva™-ATK) was evaluated in a prospective, single-arm, multicenter trial conducted at 14 U.S. sites. Adults ≥18 years with Rutherford class (RC) 2-5 peripheral arterial disease and de novo FP CTOs ≤30 cm in length with at least 1 patent distal runoff vessel were eligible. The primary endpoint was clinical success, defined as device-facilitated guidewire placement into the distal true lumen without device-related major adverse events (MAEs) within 24 hours or through discharge, benchmarked to a 70% performance goal. Angiography and/or intravascular ultrasound (IVUS) were performed before definitive therapy. Seventy-four subjects (mean age 69.4 ± 9.0 years; 35% women; 45% with diabetes mellitus; 82% current or former smokers) were enrolled, with antegrade crossing used in all cases. The mean target CTO length was 131.6 ± 90.4 mm. The primary endpoint was achieved in 87.8% (95% Confidence Interval or CI 0.78-0.94) patients overall; 90% per protocol (95% CI 0.80-0.96); in moderate-to-severe calcification (n=53), 86.7% (95% CI 0.74-0.94) overall and 88% (95% CI 0.76-0.95) per protocol. IVUS (n = 54) demonstrated 80% exclusively intraplaque crossings. The device created an angiographically visible channel (mean diameter 2.87 ± 0.74 mm; reference vessel diameter 4.9 ± 0.89 mm), corresponding to a 59% luminal gain. At 30 days, mean RC improved from 3.40 ± 0.09 to 1.25 ± 0.20 and pain score from 5.24 ± 0.36 to 2.06 ± 0.33 (both p < 0.001). No device-related MAEs occurred through 30 days. SantrevaTM-ATK demonstrated high rates of procedural success, intraplaque passage, and safety in FP CTOs, including heavily calcified lesions, with no device-related MAEs.

BACKGROUND:The authors report the intention-to-treat results for the C-GUARDIANS (Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting) pivotal trial in carotid artery stenting patients considered high risk for carotid endarterectomy, treated with this novel stent and followed for 1 year. OBJECTIVES:The authors sought to evaluate the safety and efficacy of the MicroNet-covered stent in treating patients with significant carotid stenosis at high risk of adverse events from carotid endarterectomy. METHODS:The trial is a prospective, multicenter, single-arm trial (NCT04900844). The primary endpoint was a composite of the incidence of death, all stroke, and myocardial infarction (DSMI) through 30 days postprocedure, and ipsilateral stroke from 31 to 365 days postprocedure. Secondary endpoints included the incidence of DSMI and of each individual component through 30 days, as well as the incidence of ipsilateral strokes through 30-day and 1-year follow-up. All events were adjudicated by an independent clinical events committee. RESULTS:Between July 2021 and June 2023, 316 patients with asymptomatic ≥80% or symptomatic ≥50% carotid lesions were treated with this novel stent at 24 sites in the United States and European Union using approved embolic protection systems. The DSMI rate through 30 days was 0.95% (3/316). DSMI at 30 days and ipsilateral stroke at 1 year was 1.93% (6/296). Target lesion revascularization through 1 year was 1.0% (3/299). CONCLUSIONS:The C-GUARDIAN trial demonstrated low rates of DSMI through 30 days, and ipsilateral stroke through 1 year. No unexpected adverse device effects or unexpected serious adverse device effects were reported. These results demonstrate that carotid artery stenting with this novel stent is safe, effective and durable, and supports the potential neuroprotective properties of this unique micro mesh-covered stent.

Catheter kinking/entrapment is a known complication of transradial coronary procedures. Although preventive measures are critical, operators must recognize the complication and the various methods to safely resolve it. A 71-year-old man presented with progressive angina. A coronary angiogram via the right radial artery revealed a heavily calcified, subtotally occluded right coronary artery. Attempts to engage the right coronary artery resulted in an overtorqued, kinked guide catheter within the brachial artery. Initial resolution measures were unsuccessful. A novel alternative method-the simultaneous antegrade/retrograde double-balloon-handshake-inflation (SARDHI) technique-successfully resolved the kink. The SARDHI method involved obtaining alternative access, passing a guidewire distal to the kink, inflating 2 high-pressure coronary balloons on either side of the kink, and unraveling the kink in the larger-caliber axillary artery. Catheter kinking management should be individualized to the patient's anatomy and risk factors. We present the first report of the SARDHI technique for safe kinked catheter extraction during coronary intervention. This case highlights the risk factors and early signs of a kinked transradial coronary guide catheter and frames the stepwise approach for its resolution. Techniques for preventing guide catheter kinking include resolving vessel spasm, avoiding catheter over-rotation, ensuring adequate guide support, and ensuring the guidewire remains in situ within the guide while torquing. The simultaneous antegrade/retrograde double-balloon-handshake-inflation (SARDHI) technique should be considered by proceduralists as a novel, viable method for percutaneous kinked catheter extraction given its technical ease, independence from a larger-bore catheter, and avoidance of distal catheter tip deformation.

Objective: There are varying anatomical and mechanical demands of stent placement in the iliofemoral venous segment; the Duo Venous Stent System is designed to address these issues. The purpose of the VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) study was to investigate the safety and efficacy of the Duo Venous Stent System for the treatment of patients with nonmalignant iliofemoral venous obstructive disease. Methods: This was an international, prospective, multicenter, single-arm study that enrolled patients with symptomatic non- thrombotic (NT), post-thrombotic (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety end point was freedom from major adverse events at 30 days after the index procedure. The primary efficacy end point was primary patency of stent-bearing segments at 12 months. Secondary and observational end points included symptom relief, primary-assisted patency, secondary patency, and device success. Patients remain in follow-up for 36 months. Results: A total of 162 patients were enrolled at 30 sites in the United States and Poland. The primary safety end point was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P < .0001). The primary safety end point was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy end point was met in 90.2% compared with the performance goal of 77.3% (P 1/4 .0002). Primary patency was observed in 95.2% of patients with NT disease, 79.4% of those with PTS, and 86.7% of those with aDVT. No stent fracture, migration, or embolization occurred through 12 months. Patient-reported outcomes showed improvements in Venous Clinical Severity Score, Villalta, EQ-5D-3L, and VEINES-QoL/Sym scores from baseline through 6 and 12 months. Conclusions: Through 12 months, the Duo Venous Stent System is safe and effective for the treatment of nonmalignant iliofemoral venous obstructive disease. (J Vasc Surg Venous Lymphat Disord 2025;13:101995.) Clinical Relevance: The VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) investigational device exemption trial is the first study of a hybrid, venous stent specifically designed to address the anatomic challenges of the iliofemoral venous system. The Duo Venous Stent System consists of a self- expanding nitinol Duo Hybrid Stent used independently or in conjunction with the flexible extension Duo Extend Stent. This is the first report of primary outcomes from the VIVID Study, assessing the safety and efficacy of the Duo Venous Stent System to treat patients with nonmalignant, symptomatic iliofemoral venous outflow obstruction. The Duo Venous Stent System successfully met its 12-month safety and effectiveness performance goals.

BACKGROUND:Several randomized clinical trials have shown that the composite endpoint of death, stroke, and myocardial infarction (MI) is equivalent between carotid artery stenting and carotid endarterectomy. However, the risk of minor stroke has been consistently higher with carotid artery stenting. OBJECTIVES:The authors sought to evaluate the safety and effectiveness of a novel carotid stent system comprised of a stent, an adjustable integrated embolic filter and a postdilation balloon, in patients at elevated risk for adverse events from carotid endarterectomy. METHODS:PERFORMANCE II (Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt II) was a prospective, multicenter, single-arm study. The primary endpoint was the composite of major adverse events defined as death, all stroke, and MI within 30 days of the procedure, plus ipsilateral stroke through 12 months. RESULTS:A total of 305 patients were enrolled at 32 centers in the United States and Europe. The mean age was 69.6 ± 7.5 years; 65.9% were male, and 20% were symptomatic. The mean lesion length was 19.1 ± 6.7 mm, and 34.5% of lesions were severely calcified. At 30 days, there were 4 minor strokes (1.3%), with no major strokes. There was 1 cardiac death on day 30, resulting in a stroke/death rate of 1.6% and a stroke/death/MI rate of 2.3%. The 12-month primary endpoint occurred in 2.8%; there were no major strokes, clinically driven target lesion revascularizations, stent thromboses, or neurological deaths. The 30-day all stroke plus ipsilateral stroke through 12 months rate was 1.8%. CONCLUSIONS:The rate of major adverse events was extremely low, demonstrating the study system is a safe, effective, and durable treatment option for high-risk patients. (Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt II [PERFORMANCE II]; NCT04201132).

Several randomized clinical trials have shown that the composite endpoint of death, stroke, and myocardial infarction (MI) is equivalent between carotid artery stenting and carotid endarterectomy. However, the risk of minor stroke has been consistently higher with carotid artery stenting. The authors sought to evaluate the safety and effectiveness of a novel carotid stent system comprised of a stent, an adjustable integrated embolic filter and a postdilation balloon, in patients at elevated risk for adverse events from carotid endarterectomy. PERFORMANCE II (Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt II) was a prospective, multicenter, single-arm study. The primary endpoint was the composite of major adverse events defined as death, all stroke, and MI within 30 days of the procedure, plus ipsilateral stroke through 12 months. 305 patients were enrolled at 32 centers in the United States and Europe. The mean age was 69.6 ± 7.5 years; 65.9% were male, and 20% were symptomatic. The mean lesion length was 19.1 ± 6.7 mm, and 34.5% of lesions were severely calcified. At 30 days, there were 4 minor strokes (1.3%), with no major strokes. There was 1 cardiac death on day 30, resulting in a stroke/death rate of 1.6% and a stroke/death/MI rate of 2.3%. The 12-month primary endpoint occurred in 2.8%; there were no major strokes, clinically driven target lesion revascularizations, stent thromboses, or neurological deaths. The 30-day all stroke plus ipsilateral stroke through 12 months rate was 1.8%. The rate of major adverse events was extremely low, demonstrating the study system is a safe, effective, and durable treatment option for high-risk patients. (Protection against Emboli during caRotid artery stenting using a 3-in-1 delivery system comprised oF a pOst-dilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt II [PERFORMANCE II]; NCT04201132).

Background:Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but “real-world” evidence from a larger cohort is lacking.Methods:The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab.Results:Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment.Conclusion:This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population.Clinical ImpactIn this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.

Background Little is known about treatment variability across US hospitals for patients with chronic limb‐threatening ischemia (CLTI). Methods and Results Data were collected from the 2016 to 2018 National Inpatient Sample. All patients aged ≥18 years, admitted to nonfederal US hospitals with a primary diagnosis of CLTI, were identified. Patients were classified according to their clinical presentation (rest pain, skin ulceration, or gangrene) and were further characterized according to the treatment strategy used. The primary outcome of interest was variability in CLTI treatment, as characterized by the median odds ratio. The median odds ratio is defined as the likelihood that 2 similar patients would be treated with a given modality at 1 versus another randomly selected hospital. There were 15 896 (weighted n=79 480) hospitalizations identified where CLTI was the primary diagnosis. Medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, and amputation alone were used in 4057 (25%), 5390 (34%), 3733 (24%), and 2716 (17%) patients, respectively. After adjusting for both patient‐ and hospital‐related factors, the median odds ratio (95% CI) for medical therapy alone, endovascular revascularization ± amputation, surgical revascularization ± amputation, any revascularization, and amputation alone were 1.28 (1.19–1.38), 1.86 (1.77–1.95), 1.65 (1.55–1.74), 1.37 (1.28–1.45), and 1.42 (1.27–1.55), respectively. Conclusions Significant variability in CLTI treatment exists across US hospitals and is not fully explained by patient or hospital characteristics.

Objective: Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. Methods: The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. Results: We enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. Conclusions: The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

BACKGROUND:Below-the-knee (BTK) lesions may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. Landmark interventional clinical studies have not reached consensus on the optimal standard of care for BTK lesions, and many published trials excluded patients with moderate or severe lesion calcification. Calcium modification with intravascular lithotripsy (IVL) was shown to be superior to percutaneous transluminal angioplasty in the femoropopliteal artery and successful in treating BTK lesions in pilot studies. The Disrupt BTK II study is a core laboratory-adjudicated, prospective, multicenter, single-arm study of patients with moderate to severely calcified BTK lesions treated with the Shockwave Medical Peripheral IVL System. METHODS:Disrupt BTK II enrolled 250 subjects with calcified infrapopliteal lesions and Rutherford category 3-5 presentation from 38 sites in the United States and Europe. The primary safety endpoint was major adverse limb events or postoperative death at 30 days, a composite of all-cause death, above-ankle amputation of the index limb, and/or major reintervention of the index limb involving an infrapopliteal artery. The primary effectiveness endpoint was procedural success, defined as ≤50% residual stenosis for all treated target lesions without serious core laboratory-adjudicated serious angiographic complications. The study used independent angiographic and duplex ultrasound core laboratories, and follow-up is planned through 2 years. RESULTS:A total of 305 lesions in 250 patients were treated with a procedural success of 97.9%. The mean target lesion length was 76 ± 65 mm, diameter stenosis was 78% ± 18%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core laboratory. After IVL, residual stenosis was reduced to 29%, and after optional postdilatation and/or stent implantation, to 26%. At 30 days, there were no deaths, major adverse limb event rate was 0.8%, and mean improvement in Vascular Quality of Life scores was 4.0 ± 5.0 (P < .0001). Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days. CONCLUSIONS:The Disrupt PAD BTK II study demonstrated that treatment with the Shockwave Medical Peripheral IVL System in patients with moderate-severe calcified lesions resulted in high procedural success, significant reduction in residual stenosis, improvements in patient quality of life, and wound healing, with minimal adverse events at 30-day follow-up.

OBJECTIVE:Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. METHODS:We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ2 test or Fisher exact test, as appropriate. RESULTS:A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. CONCLUSIONS:The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.

BACKGROUND:Transfemoral (TF) access is the preferred approach for transcatheter aortic valve replacement (TAVR). Limited data exist regarding the outcomes of intravascular lithotripsy (IVL)-assisted TF TAVR in patients with peripheral artery disease. OBJECTIVES:This study sought to examine contemporary characteristics, trends, and outcomes of IVL TAVR in the United States. METHODS:The Vizient Clinical Database was queried for patients who underwent percutaneous TAVR between October 1, 2020, and November 30, 2023. Outcomes with IVL TAVR vs non-IVL TAVR were examined after propensity score matching. The primary outcome was a composite of in-hospital death, stroke, vascular complications, surgical vascular intervention, and major bleeding. RESULTS:Over the study period, 129,655 patients (mean age of 78.4 years, 42.2% women, 87.1% White) underwent percutaneous TAVR at 361 hospitals, 1,242 (0.96%) of whom underwent IVL TAVR. There was an uptrend in IVL TAVR, but the frequency remained low. IVL TAVR patients had a higher median Elixhauser comorbidity score (5 [Q1-Q3: 4-7] vs 4 [Q1-Q3: 3-6]) compared to non-IVL TAVR. TAVR was completed via the TF approach in 1,238 (99.7%) IVL TAVR patients. In a 3:1 propensity score matching analysis, IVL TAVR was associated with a higher rate of the primary composite outcome (21.9% vs 13.7%; P < 0.001) driven by higher rates of vascular complications, surgical vascular intervention, and major bleeding. In-hospital death and stroke were similar in both groups. CONCLUSIONS:In the United States, IVL is increasingly adopted to facilitate TF TAVR. IVL TAVR patients exhibited a higher burden of comorbidities and experienced more complications compared to non-IVL TAVR patients. Further studies are needed to identify appropriate anatomical and clinical use criteria for IVL TAVR and to compare its outcomes vs alternative non-TF TAVR.

Purpose:Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified peripheral artery disease (PAD) in large trials and small real-world experiences. Real-world evidence from a larger cohort is lacking, so we aimed to evaluate the real-world acute performance of IVL in the treatment of calcified PAD.Materials and Methods:The Disrupt PAD III Observational Study (OS) is a prospective, multicenter, single-arm study. Patients with claudication or critical limb-threatening ischemia (CLTI) and at least moderate calcification were eligible. Independent predictors of procedural outcomes were assessed by multivariable analysis.Results:Between November 2017 and June 2021 across 30 global sites, 1373 patients with 1677 lesions (1531, 91.3% core lab evaluable) were enrolled. Diameter stenosis and lesion length was 80.6±17.6% and 93.5±74.3 mm, respectively. Target vessels included femoropopliteal (61%), iliac (15.8%), common femoral (10.7%), and infrapopliteal arteries (12.8%). Lesion characteristics included 31.1% chronic total occlusions (CTOs) and 19.3% long lesions (≥15 cm). At final assessment, residual stenosis was 23.8±11.3%, with 0.9% serious angiographic complications, no abrupt closures, distal embolization, no flow, or thrombotic events. Independent predictors of ≤30% residual stenosis were lesion length ≥15 cm (odds ratio [OR]=0.384), female sex (OR=1.850), age ≤75 years (OR=1.625), IVL balloon to artery ratio ≥1.0 (OR=1.538), and CTO lesions (OR=0.638). Lesion length ≥15 cm (OR=16.076) was an independent predictor of procedural complications.Conclusions:The Disrupt PAD III OS represents the largest assessment of IVL periprocedural outcomes in calcified PAD. It confirmed excellent procedural safety and effectiveness in complex lesions across multiple peripheral vascular beds.Clinical ImpactThis final analysis of the PAD III OS represents the largest report of peripheral IVL utilization in daily clinical practice. The outcomes of this study indicate that previously reported procedural results in clinical trial settings can be translated to a broader patient population. Treatment with peripheral IVL in severely calcified stenotic lower limb lesions demonstrated consistent acute safety and stenosis reduction, even in complex patients across multiple vessel beds. In addition, the importance of proper IVL balloon sizing to achieve excellent acute stenosis reduction was confirmed by multivariate analysis.