LAS VEGAS, November 4, 2025 /PRNewswire/ — 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 first round of Late-Breaking Clinical Trials presented at VIVA 2025, held at Wynn Las Vegas.
The first round of Late-Breaking Clinical Trial results was presented on Monday morning, highlighting pivotal studies that provide new insights into the diagnosis, treatment, and management of peripheral vascular disease.
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.
Integrated Embolic Protection in TCAR: 30-Day Results From the PERFORMANCE III Trial
Presented by: Sean P. Lyden, MD
The PERFORMANCE III trial was a prospective, multicenter, open-label, single-arm study designed to evaluate the safety and effectiveness of the Neuroguard IEP System for TCAR in patients at high risk for adverse events with CEA. The system integrates a closed-cell nitinol stent, a semicompliant post-dilation balloon, and a 40-μm embolic filter into a single device on a 70-cm delivery system, used in conjunction with an embolic protection system providing flow reversal. Together, these features deliver dual neuroprotection while streamlining procedural steps.
A total of 146 patients were enrolled in the pivotal cohort across 26 sites. ITT analysis included 145 evaluable patients (mean age 70.5 years, 21% symptomatic, 39.7% diabetic). Nearly half (49.32%) of patients met anatomic high-risk criteria and 68.5% met physiologic high-risk criteria. Lesions were predominantly de novo, with a mean diameter stenosis of 82.6% and a moderate-to-severe calcification of 98.6%.
The primary endpoint was the rate of 30-day major adverse events (death, all stroke, and MI). One MAE occurred in 1/145 ITT subjects (0.69%, cardiac death); no strokes or neurological deaths were reported. The upper bound of the 95% CI (3.78%) was well below the prespecified performance goal of 11.0%, confirming the study objective was met.
Secondary endpoints included acute (98.6%), technical (99.3%), and procedural success (98.6%), with no reports of stroke (ipsilateral, major, or minor), CNI, stent thrombosis, or blood transfusion. Mean flow reversal time was 7.4 ± 3.5 minutes.
The PERFORMANCE III trial achieved its primary endpoint with a 30-day MAE rate of 0.69%. No strokes, neurological deaths, cranial nerve injuries, or transfusions were reported, and procedural success exceeded 98%. These outcomes build upon the favorable results of PERFORMANCE II and demonstrate very low 30-day event rates with TCAR-IEP using dual neuroprotection.
Prolonged Efficacy and Safety of a Drug-Eluting Resorbable Scaffold in CLTI: 3-Year Outcomes and Subgroup Analyses From the LIFE-BTK Trial
Presented by: Sahil A. Parikh, MD
The LIFE-BTK randomized controlled trial evaluates the long-term performance of the Esprit™ BTK drug-eluting resorbable scaffold (DRS) vs percutaneous transluminal angioplasty (PTA) in patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease. This presentation highlights 3-year clinical outcomes and subgroup analyses.
At 3 years, DRS demonstrated a 33% relative improvement in the composite primary efficacy endpoint (primary patency and limb salvage) compared to PTA (59.5% vs 44.8%; P = .0025 log rank test). DRS was also associated with significantly lower rates of binary restenosis (38% vs 49%; P = .018 log rank test), and lower clinically driven target lesion revascularization rates, though the latter did not reach statistical significance (10.2% vs 18.4%; P = .052 log rank test). Safety outcomes, the composite of freedom from major adverse limb events at 3 years, and perioperative death at 30 days were similar between the 2 arms (90.8% vs 94.2%; P = .23 log rank test).
Subgroup analyses showed that the efficacy of DRS was consistent across most patient and lesion subgroups; however, significantly greater benefit was observed in patients with Rutherford-Becker class 4 disease and those not requiring inflow lesion treatment. Additional trends favoring DRS emerged in patients with none/mild calcification, mixed wound etiology, ‘Other’ race, and in those treated outside the United States.
These results support the Esprit BTK scaffold as a durable and effective endovascular treatment for CLTI, providing long-term vessel preservation, fewer reinterventions, and a comparable safety profile to PTA. The emerging subgroup signals also highlight the potential for personalized treatment strategies based on baseline clinical and anatomical characteristics.
One-Year Outcomes From the Disrupt PAD BTK II Study: Treatment of Patients With Calcified Below-the-Knee Lesions With a Peripheral Intravascular Lithotripsy System
Presented by: Ehrin Armstrong, MD
Background: Patients with calcified below-the-knee (BTK) lesions treated with intravascular lithotripsy (IVL) have demonstrated good acute results with high rates of procedural success and reduction in residual stenosis. The large population of real-world patients with calcified PAD in the Disrupt BTK II study provides a unique opportunity to assess 1-year outcomes in complex patients treated with IVL.
Materials and Methods: The prospective, single-arm Disrupt BTK II study enrolled 250 subjects of whom 200 were Rutherford category (RC) 4 or 5 and 50 were RC 3. Twelve-month endpoints included Kaplan-Meier (KM) estimates of freedom from clinically driven target lesion revascularization (CD-TLR) and major target limb amputation. Primary patency, change in RC, and Vascular Quality of Life Questionnaire-6 (VascuQoL-6) scores were also assessed.
Results: Of 250 enrolled patients, 243 received IVL therapy; through 12 months, there were 30 deaths, 18 withdrawals from the study, and 2 subjects lost to follow-up. At 12 months, the rate of primary patency was 67.1%, KM freedom from CD-TLR was 84.5%, and KM freedom from major amputation was 94.8%. At baseline, 20%, 23%, and 57% of limbs were classified as RC 3, 4, and 5, respectively. At 12 months, RC was substantially improved as 48% were asymptomatic (RC 0), 15% reported only mild claudication (RC 1), and 78% had improved their RC. The mean improvement at 12 months in total VascuQoL-6 score was 6.0 ± 5.3 and 4.5 ± 5.7 for RC 3 and RC 4/5 patients, respectively.
Conclusions: Despite the very complex anatomies and comorbidities of patients with claudication or CLTI in the Disrupt PAD BTK II study, 1-year outcomes showed promising rates of revascularization and amputations, along with improvements in RC and QoL. These results support the use of IVL in the treatment of challenging patients with complex calcified BTK lesions
Novel Thrombectomy System for Acute Intermediate-Risk Pulmonary Embolism: Full Results From the Pivotal ENGULF Trial
Presented by: Andrew Klein, MD
The ENGULF study was a prospective, multicenter, single-arm trial evaluating the Hēlo Thrombectomy System for treating acute submassive pulmonary embolism. The trial enrolled 105 patients across 19 sites with 30 operators from multiple specialties (interventional cardiology, interventional radiology, and vascular surgery).
The study met both primary endpoints with statistical significance (P < .001). For effectiveness, patients demonstrated a 25.1% reduction in RV/LV ratio (0.4 absolute decrease) from baseline to 48 hours, exceeding the prespecified goal of >0.12 improvement. For safety, the major adverse event rate was 0.95% (1/105 patients), well below the prespecified goal of 25% based on literature, with no device-related deaths.
The Hēlo Thrombectomy System features an innovative design with continuous aspiration, a 24F clot engagement zone, and orbital agitator thrombectomy for clot remodeling to maintain a 15F heart crossing profile. Key procedural outcomes included a 39-minute device time and zero device corking incidents.
Secondary endpoints showed substantial clinical benefit: 16.6% reduction in systolic pulmonary artery pressure, 16.9% reduction in mean pulmonary artery pressure, and 16.2% reduction in Modified Miller score. The introduction of a blood return system during the trial reduced median blood loss from 340 mL to 10 mL, further completing the Hēlo platform.
The safety profile was excellent with no major bleeding, pulmonary vascular injury, or cardiac injury at 48 hours. At 30 days, all-cause mortality was 2.85%, device-related serious adverse events was 2.85%, and symptomatic PE recurrence was 3.80%.
Operator feedback during enrollment led to successful device iterations, resulting in a complete thrombectomy system with comparable pressure reduction to large-bore device trials while maintaining an exceptional safety profile and minimal blood loss.
STRIKE-PE: 1-Year Functional Outcomes and Quality of Life in Pulmonary Embolism Patients Treated With Computer-Assisted Vacuum Thrombectomy Using the 16F Catheter System
Presented by: John Moriarty, MD
Purpose: This analysis of the STRIKE-PE study reports functional outcomes and quality of life (QOL) at 1 year for pulmonary embolism (PE) patients treated with computer-assisted vacuum thrombectomy (CAVT) using the novel 16F catheter system.
Materials and Methods: STRIKE-PE is a single-arm, prospective, multicenter, ongoing trial designed for up to 1500 patients. Among the first 595 patients enrolled, 244 were treated with CAVT using the novel 16F catheter system. The primary endpoints of STRIKE-PE are change in right ventricular/left ventricular (RV/LV) ratio from baseline to 48 hours and composite major adverse events (MAEs) at 48 hours. Functional outcomes and QOL were evaluated at 90 days and 1 year.
Results; Mean RV/LV ratio decreased from 1.34 at baseline to 0.95 at 48 hours (Δ 27.3%; P < .001). The composite MAE rate was 0.8% (2 patients).
All functional outcomes were improved at 1 year; from 90 days to 1 year all improvements were sustained. Median Borg dyspnea scale at rest improved, decreasing from 4.0 at baseline to 0.0 at 1 year (P < .001). Mean 6-minute walk test distance increased from 222.5 meters at discharge to 370.7 meters at 1 year (P < .001). The NYHA classification distribution at 1 year recovered to that of before the PE event.
Mean EQ-5D-5L index value increased from 0.398 at baseline to 0.815 at 1 year (P < .001) and mean EQ-Visual Analogue Scale increased from 50.5 at baseline to 77.3 at 1 year (P < .001); these improvements were also sustained from 90 days to 1 year. Mean total PEmb-QoL improved, decreasing from 43.7 at baseline to 14.2 at 1 year (P < .001), a continued improvement from the 90-day result (P < .001).
Conclusions: In STRIKE-PE, patients treated with the 16F catheter system significantly improved their functional outcomes and QOL to 1 year. These findings demonstrate that treatment with CAVT using the 16F catheter system enhances patient outcomes and potentially reduces the long-term burden of PE-related sequelae.
Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation vs Anticoagulation Alone for Acute Intermediate- High-Risk PE: Primary Outcome, Functional Endpoints, and Core Lab Findings From STORM-PE
Presented by: Rachel Rosovsky, MD, MPH
STORM-PE is the first randomized controlled trial (RCT) to test the efficacy and evaluate the safety of mechanical thrombectomy using computer-assisted vacuum thrombectomy (CAVT) with anticoagulation (AC) vs AC alone in patients with acute intermediate-high-risk pulmonary embolism (PE). Functional endpoints, clinical parameters, and core lab findings were also analyzed.
Patients with acute (symptoms ≤14 days) intermediate-high-risk PE confirmed by a right-to-left ventricular (RV/LV) ratio ≥1.0 on CTPA and elevated cardiac biomarkers were randomized 1:1 to treatment with either CAVT + AC (CAVT arm) or AC alone (AC arm). The primary endpoint was the difference between groups in RV/LV ratio changes at 48 hours. Secondary endpoints include composite major adverse events (MAEs) within 7 days and functional assessments (eg, PVFS Scale, mMRC, Borg Scale, 6MWT). Core lab parameters included pulmonary artery (PA) obstruction index (MMS and RMMS) and IVC reflux. Clinical parameters included vital signs and National Early Warning Score 2 score (risk of clinical deterioration).
The reduction in RV/LV ratio was greater in the CAVT vs the AC arm (P < .001) with similar MAE rates (P = .681). The reduction of PA obstruction was also greater in the CAVT arm (P < .001). At 48 hours, less tachycardia and lower oxygen requirements were present in the CAVT arm vs the AC arm (2.2% vs 20.8%; P =.005 and 0.5 L/min vs 1.4 L/min; P =.027, respectively). Patients in the CAVT arm had a greater improvement in PVFS scores at discharge compared to the AC arm (P =.022).
In STORM-PE, the CAVT arm demonstrated superior reduction in RV dilatation with a similar safety profile to the AC arm. The CAVT arm also demonstrated functional assessment improvements, earlier physiological recovery, and greater reduction in PA obstruction vs the AC arm. These findings reinforce the role of mechanical thrombectomy as an effective treatment strategy in patients with acute intermediate-high-risk PE.
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.
To learn more about the VIVA Foundation, visit https://viva-foundation.org/
