The VIVA Foundation, a not-for-profit organization dedicated to advancing vascular medicine through education and research, today announced results from four Late-Breaking Clinical Trials presented at The VEINS 2026 conference, held at Bellagio Las Vegas.
The VEINS (Venous Endovascular INterventional Strategies) complements this tradition with a dedicated focus on the diagnosis, intervention, and management of venous disorders, creating a comprehensive educational experience across the full vascular spectrum.
Effects of Iliac Vein Stent Placement on Quality of Life in Patients With Post-Thrombotic Syndrome: 24-Month Results From the NIH-Sponsored C-TRACT Randomized Trial
Presented by Suresh Vedantham, MD
Purpose: In the Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy (C-TRACT) Trial, endovascular therapy (EVT) reduced post-thrombotic syndrome (PTS) severity and improved health-related quality of life (QOL) through 6-month follow-up. The current analysis evaluated the effects of EVT on 24-month QOL and safety outcomes.
Materials and Methods: Patients with moderate or severe PTS and iliac vein obstruction (occlusion or > 50% stenosis) were randomized to receive EVT (iliac vein stent placement and enhanced anti-thrombotic therapy for 6 months) plus standard PTS care versus standard PTS care alone in 29 U.S. centers. Of 225 patients randomized, the first 197 patients self-reported their QOL at baseline and 6, 12, 18, and 24 months using the VEINES-QOL questionnaire (venous disease-specific QOL) and Medical Outcomes SF-36 Health Survey (generic QOL). Linear mixed model-derived mean scores were compared between the EVT and No-EVT groups, as were rates of recurrent venous thromboembolism (VTE), bleeding, and death.
Results: At 24 months, QOL was better in the EVT group than in the No-EVT group (VEINES-QOL scale points: EVT 63.5 (Standard Error [SE] 3.0) versus No-EVT 53.0 (SE 2.8), adjusted difference 10.5 [4.6, 16.4], p<0.001; and SF-36 Physical Component Summary Scale points: EVT 56.3 (SE 1.8) versus No-EVT 51.2 (SE 1.7), adjusted difference 5.2 [1.5, 8.9], p=0.006). EVT also improved venous symptoms (VEINES-Sym points: EVT 61.4 (SE 3.1) versus No-EVT 54.1 (SE 3.0), adjusted difference 7.3 [1.0, 13.6], p=0.02). Through 24 months, the occurrences of symptomatic recurrent VTE (EVT 2.1%, No-EVT 7.1%), any bleeding (EVT 15.5%, No-EVT 8.1%), major bleeding (EVT 4.1%, No-EVT 2.0%), and death (EVT 2.1%, No-EVT 3.0%) did not differ between groups.
Conclusions: In patients with moderate-or-severe PTS and iliac vein obstruction, endovascular iliac vein stent placement improved venous disease-specific and generic physical health-related QOL through 24-month follow-up, without significantly increasing major safety events.
1-Year Functional Outcomes and Quality of Life for Pulmonary Embolism After Mechanical Thrombectomy of 1,000 Prospective Patients
Presented by Andrew Holden, MBChB
STRIKE-PE is a prospective, international, single-arm study evaluating the safety, effectiveness, and long-term clinical outcomes of computer-assisted vacuum thrombectomy (CAVT) treatment of intermediate- or high-risk acute pulmonary embolism (PE). Up to 50% of PE survivors experience persistent functional limitations and compromised quality of life (QOL), indicative of post-PE syndrome. Assessing longer-term functional outcomes and QOL after PE treatment can identify patients with ongoing complications such as post-PE syndrome and can document improvement trajectories.
STRIKE-PE enrolled patients with acute PE (≤14 days) and a right-to-left ventricular (RV/LV) ratio of ≥0.9. This analysis is the first report of 1000 patients treated with CAVT and includes 1-year follow-up data from 522 patients.
Patients’ mean age was 61.9 years and 52.8% were male. Median thrombectomy time was 28 minutes. The primary effectiveness endpoint, change in RV/LV ratio, improved from 1.38 at baseline to 0.97 at 48-hour follow-up, a 27.2% reduction (P<.001). The primary safety endpoint, composite major adverse event rate at 48 hours, was 1.9%. Device-related serious adverse events occurred in 0.4% of patients. Thirty-day all-cause mortality and recurrent symptomatic PE rates were 1.7% and 0.6%, respectively.
Substantial improvements in dyspnea and QOL were observed by 90 days (P<.001); these gains were either sustained or further improved from 90 days to 1 year. The 6-minute walk distance improved from 90 days to 1 year (P<.001). The NYHA functional class distribution returned to pre-PE levels at 90 days then was sustained to 1 year.
STRIKE-PE continues to demonstrate safety and effectiveness of CAVT for treating PE. Short-term clinical improvement after treatment of PE with CAVT is accompanied by longer-term benefits of reduced dyspnea, increased functional capacity, restored pre-PE functional status, and improved quality of life. These findings suggest sustained clinical benefit and potential for reduced burden of post-PE syndrome after PE treatment with CAVT.
Safety and Efficacy of Mechanical Thrombectomy for Patients With Deep Vein Thrombosis: Primary Results From the Prospective, Multicenter IDE BOLT Study
Presented by Patrick E. Muck, MD
BOLT is a prospective, multicenter, Investigational Device Exemption (IDE) trial that evaluated the safety and effectiveness of computer-assisted vacuum thrombectomy (CAVT) as a first-line treatment for patients with acute iliofemoral deep vein thrombosis (IFDVT). Although prior studies have demonstrated that endovascular intervention can reduce thrombus burden and improve patient outcomes, much of the available evidence was generated using older technologies and fibrinolytic use where interventions were not usually single-session. BOLT was designed to assess outcomes with a contemporary mechanical thrombectomy approach.
A total of 229 patients were enrolled across 39 U.S. sites (mean age 58.1 years; 62.0% female). The primary effectiveness endpoint was core-lab adjudicated complete or near-complete (≥75%) thrombus reduction from the target venous segment measured by Marder Score. The primary safety endpoint was CEC-adjudicated composite major adverse events (MAE) within 48 hours. Other outcomes included 30-day composite MAEs, device-related AEs, and Villalta Score.
Complete or near-complete thrombus reduction (Marder) was achieved in 98.0% of patients (198/202; P<.001). The 48-hour MAE rate was 3.1% (7/229; P<.001). No device-related deaths or serious device-related adverse events occurred and rates of major bleeding, symptomatic pulmonary embolism, and re-thrombosis within 48 hours were low at 1.3%, 0.9%, and 1.3%, respectively.
Device time was 18.0 minutes and 99.1% of cases were single-session. At 30 days, secondary endpoint composite MAEs occurred in 7.6% with re-thrombosis in 3.9%. Villalta Score, a measure of post-thrombotic symptoms, improved from 11.0 to 1.0 (P<.001) from baseline to 30 days.
In BOLT, both predefined primary effectiveness and safety endpoints were met. Following treatment with CAVT, patients experienced a 100% median reduction in thrombus accompanied by low MAE and rethrombosis rates. Clinical improvement through 30 days was observed across multiple measures. These findings support a contemporary, single-session endovascular therapy strategy. The BOLT trial is ongoing with follow-up to 2 years.
Safety and Effectiveness of the Recana Thrombectomy Catheter System for the Treatment of Venous In-Stent Restenosis and Residual Vein Obstruction
Presented by Stephen Black, MD
Residual vein obstruction (RVO) is defined as the persistent presence of thrombotic material several months after deep vein thrombosis (DVT). Venous in-stent restenosis (ISR) is a common complication following venous stenting and is best described as a narrowing of the vein lumen after stent placement. Both are chronic processes in which the fibrin-rich structure progressively develops into collagen, forming fibrous synechiae. Treatment of RVO and ISR remains challenging as conservative therapy, balloon venoplasty and stent-relining do not remove material, limiting their long-term efficacy. This study evaluates the safety and effectiveness of debulking chronic ISR and RVO with an integrated mechanical thrombectomy system.
This multicenter prospective analysis includes patients undergoing intervention for symptomatic chronic obstructions and occlusions within stented and non-stented venous segments with an integrated mechanical thrombectomy system. Patients were: (1) ≥18 years old; (2) had symptomatic chronic venous disease (CVD) with edema (CEAP classification of C3 or greater) or pain; (3) diagnosed with flow-limiting venous inflow/outflow obstruction (>50%) within the intended target vessels, including the IVC/common iliac confluence, femoral, popliteal and inflow. The primary effectiveness end point was defined as achieving an effective diameter of ≥50% at procedure completion as assessed by intravascular ultrasound. An independent Data Monitoring Committee (DMC) was constituted to ensure trial oversight.
All interventions were completed in a single session. General anesthesia was administered in all cases (100%). Post-procedure, 96.2% of target limbs achieved patency. The mean procedure time was 107 minutes. Mean lumen area increased from 12.5 mm2 to 92.7 mm2 per segment. The mean post-procedure hospital length of stay was 1.4 days.
Mechanical thrombectomy with the study device achieved significant material debulking in chronic, complex ISR, restoring patency in 96.2% of target limbs with an 8-fold increase in lumen area. These findings highlight the system’s potential to recanalize occluded venous stents and enhance cephalad flow. Further studies are needed to confirm long-term patency outcomes.
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/.
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