The VIVA Foundation, a not-for-profit organization dedicated to advancing vascular medicine through education and research, announced results from six Late-Breaking Clinical Trials presented this morning at VIVA 2026, held at Bellagio Las Vegas.
For 24 years, VIVA (Vascular InterVentional Advances) has set the benchmark for premier education and clinical excellence in peripheral vascular disease. Known for delivering the most up-to-date, practice-changing data, VIVA brings together the latest science, technological innovation, and international expertise.
Results From Pulsatile Intravascular Lithotripsy to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease (POWER PAD II)
Presented by Jon C. George, MD, MBA
The POWER PAD II study was a prospective, single-arm, multicenter IDE clinical study to demonstrate the safety and effectiveness of the Pulse IVL system for treatment of calcified femoral and popliteal arteries in PAD subjects. The Pulse IVL system propagates hydraulic pressure waves through a noncompliant balloon to modify surrounding calcium.
A total of 115 subjects across 17 US sites were enrolled and treated with the Pulse IVL system. The mean age was 72 years and 65% of subjects were male. Almost 75% of the subjects were Rutherford class (RC) 3 and the majority had a history of hypertension and dyslipidemia. All lesions met the PARC definition of severe calcium, with an average lesion length of 86 mm and 82% stenosis. Most of the lesions were in the superficial femoral artery (72%) with both concentric and eccentric calcium present in 70% of the lesions.
The study met both its primary safety and effectiveness endpoints. For effectiveness, 98.3% of the subjects had a final residual diameter stenosis of <50%. For safety, 98.3% of subjects were free from new onset Major Adverse Events (MAE) within 30 days post-procedure. There were no serious adverse events related to the device. The study also demonstrated sustained results up to six months of follow-up. Patency was 94% and 91% at 30 days and 6 months, while the percentage of subjects with RC improvement was 88% and 93% at 30 days and 6 months, respectively. Ankle-brachial index increased from 0.76 at baseline to 0.99 at both 30 days and 6 months. No subjects required clinically driven target lesion revascularization.
The POWER PAD II study results demonstrate that the Pulse IVL system can be used for the treatment of calcific femoropopliteal disease.
Calcified Below-the-Knee Lesions Treated With the Shockwave Medical Peripheral Intravascular Lithotripsy System: Two-Year Outcomes From the DISRUPT PAD BTK II Study
Venita Chandra, MD
Background: Moderate-to-severely calcified infrapopliteal lesions remain among the most challenging lesions to treat and are increasingly encountered in patients with peripheral artery disease. Intravascular lithotripsy (IVL) for the treatment of patients with calcified below-the-knee (BTK) lesions has demonstrated excellent procedural success, low residual stenosis, and favorable one-year outcomes. This analysis reports two-year outcomes from the DISRUPT PAD BTK II study.
Materials and Methods: The prospective, multicenter, single-arm DISRUPT PAD BTK II study enrolled 250 subjects, of which 200 patients were Rutherford category (RC) 4 or 5 and 50 were RC3. Two-year endpoints included Kaplan-Meier (KM) estimates of freedom from clinically driven target lesion revascularization (CD-TLR) and major target-limb amputation. Major adverse limb events (MALE), change in RC, and VascuQoL scores were also assessed.
Results: 243 of the 250 patients received IVL therapy and there were 46 deaths, 30 withdrawals from the study, and 14 subjects lost to follow-up through 2 years. The two-year KM estimates of freedom from CD-TLR excluding amputation and major amputation for the full cohort were 81% and 94.8%, respectively. For the full cohort, the two-year rates of MALE, all-cause death, and above-the-ankle amputation were 29.1% (58/199), 23.8% (46/193), and 7.7% (12/155), respectively. Among eligible patients with follow-up, 76.6% were asymptomatic (RC0) or reported only mild claudication (RC1) at 2 years, and 85.2% had improved by at least one RC category. The mean improvement in total VascuQoL score at 2 years among evaluable patients was 5.8 ± 5.5 (p<0.001).
Conclusions: In the DISRUPT PAD BTK II study, patients with heavily calcified below-the-knee disease treated with IVL had low rates of repeat revascularization and major amputation, and had significant improvement in quality of life. These results support the long-term safety and effectiveness of IVL in the treatment of challenging patients with complex calcified BTK lesions.
Adjunctive Transdermal Continuous Oxygen Therapy Accelerates Surgical Wound Healing After Lower Extremity Revascularization: A Randomized Clinical Trial
Presented by Khanjan Nagarsheth, MD, MBA
Surgical site complications following lower extremity revascularization remain common and can contribute to prolonged recovery, graft complications, and limb loss. Transdermal continuous oxygen therapy (TCOT) delivers concentrated oxygen directly to the wound environment; however, its effectiveness in accelerating healing of postoperative vascular surgical incisions has not previously been evaluated in a randomized clinical trial.
This prospective, single-center randomized trial evaluated 118 adults undergoing elective lower extremity revascularization for atherosclerotic peripheral arterial disease. Following skin closure, patients were randomized 1:1 to TCOT using the EPIFLO device (3.0 mL/hour of 98%–100% oxygen for 28 days) plus standard wound care or standard wound care alone. Incision healing was assessed through 28 days using the modified Bates-Jensen Wound Assessment Tool, with follow-up through 90 days. The primary endpoint was the trajectory of incision healing over four weeks; surgical site infection was a secondary endpoint.
TCOT significantly accelerated wound healing compared with standard care (treatment effect 0.0060; 95% CI, 0.0014–0.0107; P=0.01). Complete healing at four weeks occurred in 69% of TCOT-treated patients versus 50% of controls (P=0.01), representing a 19-percentage-point absolute improvement. Median time to complete healing was reduced from 40 days with standard care to 25 days with TCOT. Surgical site infections occurred in three control patients and no TCOT patients (P=0.09), and no device-related adverse events were observed.
These findings demonstrate that adjunctive TCOT can significantly accelerate surgical incision healing following lower extremity revascularization. Larger multicenter studies are warranted to confirm these findings and define its role in postoperative vascular surgical care.
1-Year Outcomes From the PROMISE III Trial of Transcatheter Arterialization of the Deep Veins
Presented by Daniel G. Clair, MD
A subset of patients with chronic limb-threatening ischemia (CLTI) are not eligible for conventional endovascular or surgical revascularization treatment options and face poor outcomes, including high rates of mortality and major amputation. Transcatheter arterialization of the deep veins (TADV) with the purpose-built LimFlow System has demonstrated positive outcomes in the prior PROMISE trials. We report here the 1-year outcomes from the PROMISE III trial.
The PROMISE III trial is a prospective, multicenter, single-arm study. All enrolled patients had Rutherford class 5/6 disease and were independently confirmed as ineligible for endovascular or surgical interventions. Key exclusion criteria included systemic infection, rapidly deteriorating wounds, or advanced heart failure. Study conduct included an independent clinical events committee to adjudicate safety outcomes and a core laboratory to assess all wound images. Outcomes assessed through 1 year included Kaplan-Meier (KM) rates of limb salvage, survival, and amputation-free survival (AFS), as well as pain (0-10 score), wound healing status, and Rutherford classification.
A total of 100 patients (103 limbs) underwent TADV. All included limbs had non-healing ulcers or gangrene with 74.8% Rutherford class 5 and 25.2% class 6. Preexisting comorbidities included 80.0% with diabetes, 95.0% with hypertension, 63.0% with hyperlipidemia, 46.0% with chronic kidney disease, and 13.0% on dialysis.
At 1 year, the KM limb salvage rate was 84.1%, survival was 91.4%, and AFS was 76.3%. Pain decreased from a median of 6 at baseline to a median of 0 at 1 year. Wounds were completely healed or healing in 91.5% of treated limbs at 1 year. 64.1% of patients were in Rutherford class 4 or below with 45.3% in Rutherford class 0 (asymptomatic).
The 1-year outcomes from the PROMISE III trial build upon the favorable outcomes of the prior PROMISE studies and support the use of TADV in the treatment of no-option CLTI patients.
12-Month Outcomes for Patients with Complex PAD Conditions (Diabetes Mellitus, CTO, Long Lesions, and/or Calcified Lesions) Treated With DES From the ELEGANCE Registry
Presented by Eric A. Secemsky, MD, MSc
Purpose: The ELEGANCE registry prospectively evaluates endovascular PAD treatment using Ranger drug-coated balloon (DCB) or Eluvia drug-eluting stent (DES) with a focus on historically underrepresented populations to generate real-world evidence. The purpose of this analysis is to examine 12-month outcomes for ELEGANCE patients treated with DES by complex patient groups that are at higher risk for complications or restenosis.
Design: ELEGANCE registry patients who were treated with DES for femoropopliteal lesions and had completed the 12-month follow-up window were included. Complex patient subgroups were defined as: current diabetes mellitus (DM), chronic total occlusions (CTO), long lesions (LL) ≥150 mm, or lesions with moderate/severe calcification (Ca+). Kaplan-Meier analysis was used to estimate site-reported primary patency, freedom from CD-TLR, and freedom from major (above-ankle) amputation at 12 months.
Results: Among 382 DES-treated patients with 405 lesions, complex disease was common: 55.7% had current and medically-treated DM (N=195 patients), while 61.5% of lesions were CTOs (N=240 patients), 33.3% had LL ≥150 mm (N=135 patients), and 63.9% had moderate/severe Ca+ (N=241 patients). Overall, 36.2% of patients in this cohort had CLTI (Rutherford classification 4-6) at baseline. Clinical outcomes were favorable after 12 months, including primary patency of 93.2 ± 1.3%, freedom from CD-TLR of 94.1 ± 1.2%, and freedom from major amputation of 99.4 ± 0.4%. These findings were consistent across subgroups within DM, CTO, LL ≥150mm, and moderate/severe Ca+ subgroups, showing a range for primary patency of 93.6%–94.2%, freedom from CD-TLR of 94.2%–95.9%, and freedom from major amputation of 99.1%–99.6%.
Conclusion: Real-world patients from the ELEGANCE registry treated with DES for femoropopliteal lesions showed positive 12-month outcomes, including primary patency, freedom from CD-TLR, and freedom from major amputation. These outcomes remained consistent even when focusing on complex patient subgroups that historically have expectations of poorer outcomes and higher rates of restenosis.
About the VIVA Foundation
The VIVA Foundation is a nonprofit organization dedicated to advancing vascular medicine through education and research. Bringing together experts in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery, the Foundation provides multidisciplinary education designed to improve patient care and advance innovative therapies for vascular disease worldwide.
To learn more about the VIVA Foundation, visit https://viva-foundation.org/.
Media personnel should contact press@viva-foundation.org with questions.
