The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, today announced results from the third round of Late-Breaking Clinical Trials presented at VIVA 2025, held at Wynn Las Vegas.
VIVA (Vascular InterVentional Advances) is an annual vascular education symposium that brings together a global, multispecialty faculty to present the latest research and clinical data. The program is attended by interventional cardiologists, interventional radiologists, vascular surgeons, and specialists in endovascular medicine, providing unparalleled access to cutting-edge advances in vascular care.
Transcatheter Arterialization of the Deep Veins: Initial 6-Month Outcomes From the PROMISE III Trial
Presented by: Daniel Clair, MD
A subset of approximately 10% of patients with chronic limb-threatening ischemia (CLTI) have historically lacked viable options for conventional surgical or endovascular revascularization and face poor outcomes, including high major amputation rates. Transcatheter arterialization of the deep veins (TADV) with the purpose-built LimFlow System (Inari Medical, Irvine, CA) has demonstrated positive outcomes in no-option CLTI patients in the early feasibility PROMISE I trial and the pivotal PROMISE II trial. The PROMISE III trial is a continued-access, post-market study of the LimFlow System. This work reports the 6-month primary endpoint outcomes from the PROMISE III trial.
The PROMISE III trial is a prospective, multicenter, single-arm study of Rutherford class 5/6 CLTI patients who were confirmed ineligible for endovascular or surgical interventions by an independent physician review committee. Key exclusion criteria were 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. The primary endpoint was 6-month amputation-free survival (AFS), defined as freedom from both major (above-ankle) amputation of the index limb and all-cause mortality. Other endpoints included limb salvage, survival, wound status, and pain assessed through 6 months.
A total of 100 patients (103 limbs) underwent TADV between 2022 and 2024. All included limbs had nonhealing ulcers or gangrene with 75% Rutherford class 5 and 25% class 6. Technical success was 97%. At 6 months, the primary endpoint of AFS was 80.7%, limb salvage was 86.5%, and survival was 93.8%. Approximately 80% of wounds were completely healed or healing at 6 months. The median pain score was 2.0 at 6 months, significantly decreased from 6.0 at baseline (P < .0001).
The 6-month outcomes from the PROMISE III trial further reinforce the evidence for TADV with the LimFlow System for no-option CLTI.
Peripheral Retrievable Stent Therapy: DEEPER REVEAL Clinical Trial 6-Month Outcomes
Presented by: Mahmood Razavi, MD
Trial and Design: The DEEPER REVEAL trial is a prospective, single-arm, multicenter trial that enrolled 130 subjects in the United States, with in-person follow-up through 12 months post procedure. The study was designed to evaluate the safety and efficacy of a novel device, the Spur, a retrievable stent covered in circumferential spikes in patients with chronic limb-threatening ischemia (CLTI) of the infrapopliteal arteries. The device is an over-the-wire, 6-French–compatible system, which is inserted, deployed, and retrieved following treatment, leaving nothing behind.
Results: The majority of enrolled subjects had diabetes (74.6%), and more than 60% were Rutherford class 5; lesion characteristics showed a mean lesion length of 96.38 mm.
The primary endpoints, compared to performance goals, were met and previously reported. The primary efficacy endpoint of technical success (<30% residual stenosis) was 99.2% with one bailout stent, and freedom from the occurrence of MALE and perioperative death (POD) within 30 days post procedure was 96.9%.
At 6 months, secondary safety endpoints of freedom from MALE, limb salvage, and all-cause mortality (KM analysis) were 94.0%, 96.5%, and 4.7%, respectively.
Secondary efficacy endpoints at 6 months demonstrated primary patency by duplex ultrasound (75.3%), freedom from CD-TLR (85.5%), complete wound healing (74.2%), improvement in Rutherford class score (71.3%), and statistically significant improvement in quality of life scores from baseline.
Conclusions: In the DEEPER REVEAL study, primary safety and efficacy endpoints were met, demonstrating high rates of acute success compared to previous data with balloon angioplasty. Positive safety and clinical outcomes were demonstrated at 6 months, suggesting that acute success obtained with retrievable stent therapy may lead to long-term clinical improvements for patients with CLTI.
MOTIV BTK RCT: Safety and Effectiveness Study of the MOTIV Sirolimus-Eluting Bioresorbable Coronary Scaffold Compared with Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions–Primary Safety Endpoint
Presented by: Ehrin Armstrong, MD
The MOTIV device is a fully resorbable scaffold, manufactured from Tyrocore™, an iodinated, polycarbonate copolymer of tyrosine analogs. MOTIV is completely radiopaque, enabling precise edge-to-edge placement of multiple scaffolds for complete coverage of longer target lesions. The MOTIV BTK study is a prospective, multicenter, single-blind, randomized controlled trial that enrolled 292 subjects in the primary patient cohort presenting with Rutherford category 4 or 5 CLTI due to de novo lesions in native infrapopliteal arteries suitable for endovascular intervention. The study included treatment of lesions in vessels averaging 2.5-3.75 mm in diameter, with up to 2 lesions and a maximum total scaffold length of 120 mm permitted.
Subjects were randomized 1:1 (stratified by enrolling site and medically treated diabetes vs no medically treated diabetes) to one of 2 treatment arms (interventional–MOTIV or control–PTA with standard uncoated balloon). All subjects are undergoing clinical follow-up at 30 days, 6 months, and 1, 2, and 3 years. Duplex ultrasound (DUS) is being performed at 30 days, 6 months, and 1 year. Telephone follow-up will be conducted at 4 and 5 years.
A total of 68% of the patients were classified as Rutherford 5 with only 32% Rutherford 4. The average preintervention diameter stenosis was more than 89% with approximately 29% of the patients having moderate calcification. The average treated vessel diameter was 3.01 mm with an average target lesion length of 50.4 mm. All patients have completed their 30-day clinical follow-up visits.
The primary safety endpoint is defined as freedom from MALE and all-cause POD, evaluated at 30 days and defined as freedom from the composite of allcause death, above-the-ankle amputation, or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.
In the MOTIV BTK study, the MOTIV sirolimus-eluting bioresorbable coronary scaffold demonstrated favorable preliminary safety outcomes through the 30-day time point. Patient follow-up through a total of 5 years is ongoing and outcomes for the primary efficacy endpoint will be presented soon.
One-Year Outcomes From the FORWARD PAD IDE and Feasibility Studies of the Treatment of Calcified PAD With a Novel Forward Peripheral Intravascular Lithotripsy System
Presented by: Andrew Holden, MBChB
Background: Severe calcification, chronic total occlusions (CTOs), and medial calcification are obstacles for endovascular treatment of peripheral artery disease (PAD) and contribute to high mortality and amputation rates. In complex patients, current calcium modification technologies can be limited by an inability to deliver across severely stenosed lesions and associated risks of vessel damage and distal embolization. The novel Javelin intravascular lithotripsy (IVL) catheter uses acoustic pressure waves to safely modify calcification in extremely narrow crossing channels where other devices may be limited.
Methods: In the FORWARD PAD IDE and Feasibility Studies, 110 patients with 124 core lab-assessed lesions were enrolled. Twelve-month endpoints included major adverse events (MAEs), cardiovascular death, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, and patency.
Results: Baseline lesion characteristics included 83.9% with severe calcification, diameter stenosis of 83.0 ± 17.4%, and 41.7% chronic total occlusions. At final angiography, patients had an acute gain of 2.8 ± 1.2 mm, residual stenosis of 23.1 ± 8.6%, and there was only one type D dissection. The 12-month overall rate of MAE was 18.6% (19/102), with 3.9% (4/102) of subjects experiencing cardiovascular death, 1.0% (1/102) with major amputation, and 14.7% (15/102) having CD-TLR. Primary, primary-assisted, and secondary patency in ATK lesions were 72.7%, 74.5%, and 76.4%, respectively. Primary, primary-assisted, and secondary patency in the BTK lesions were 61.5%, 78.4%, and 88.6%, respectively.
Conclusions: In heavily calcified and severely stenosed or completely occluded lesions, treatment with the Javelin IVL system resulted in stenosis reduction and acute gains without perforations or embolization consistent with the prior balloon-based IVL studies. The 1-year patency, amputation, and revascularization rates were comparable to prior clinical trials of heavily calcified lesions. Continued real-world assessments are ongoing to determine how the Javelin IVL catheter fits in the armamentarium of calcium-modifying technologies.
Results From Pulse IVL™ to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Peripheral Artery Disease: POWER PAD II
Presented by: D. Christopher Metzger, MD
Purpose: The POWER PAD II study is a prospective, multicenter, single-arm study to demonstrate the safety and effectiveness of the Amplitude Vascular System (AVS) Pulse Intravascular Lithotripsy™ (Pulse IVL™) System for treatment of calcified, stenotic superficial femoral and popliteal (SFA/POP) arteries in patients with peripheral arterial disease. Eligibility criteria included moderate to heavily calcified SFA/POP arterial disease, Rutherford category 2 to 4 symptoms, reference vessel diameter 4 mm to 6.5 mm, and total lesion length of ≤150 mm.
Materials and Methods: Patients were enrolled at sites in the United States and followed for 6 months. The primary effectiveness endpoint is the proportion of patients who achieved a residual diameter stenosis of <50% post Pulse IVL procedure and after adjunctive therapy. The primary safety endpoint is freedom from major adverse events (MAEs) within 30 days from the Pulse IVL procedure, defined as emergency surgical revascularization of target limb, unplanned target limb amputation, symptomatic thrombus or distal emboli, or perforations or dissections of grade D or greater that require bailout stenting. An independent core lab adjudicated all angiograms at the time of the procedure, and an independent clinical events committee reviewed all adverse events.
Results: The POWER PAD II study is a US pivotal trial to examine the safety and efficacy of the AVS Pulse IVL System for treatment of severely calcified femoral and popliteal arterial disease.
Conclusions: In addition to the previously presented primary endpoints, we anticipate presenting results for unique subsets of patients.
About the VIVA Foundation
The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research, strives to be the premier educator in the field. Our team of specialists in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery is driven by the passion to advance the field and improve patient outcomes. Educational events presented by the VIVA Foundation have a distinct spirit of collegiality attained by synergizing collective talents to promote awareness and innovative therapeutic options for vascular disease worldwide.
