LAS VEGAS, Oct. 4, 2026 /PRNewswire/ — The VIVA Foundation, a not-for-profit organization dedicated to advancing the field of vascular medicine through education and research, today announced results from the Late-Breaking Clinical Trials presented at The VEINS 2026 conference, held at Bellagio Las Vegas.

Late-Breaking Clinical Trial results were unveiled during sessions on Saturday and Sunday, October 3 and 4, showcasing new data that advance the understanding and treatment of venous disease.

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.

Prospective Clinical Trial Evaluating Cyanoacrylate Closure in Patients With C6 Disease: Spectrum Secondary Outcomes through 24 Months
Presented by Manj Gohel, MD

Purpose: Cyanoacrylate closure (CAC) for saphenous ablation of chronic venous disease (CVD) is effective for patients with C2-C5 disease. Patients with VLUs may require a modified treatment approach given the severity of disease, and they are often excluded from clinical research. These 24-month secondary outcomes report on the durability of CAC for C6 disease.

Materials and Methods: This was a prospective, single-arm observational study conducted in the United States and Europe at 17 sites. The VenaSeal closure system was used to treat 125 participants in addition to wound and compression therapy as per the local standard of care. Investigators were permitted to utilize adjunctive treatments to the sub-ulcer plexus or incompetent perforators at the time of the index procedure. Secondary outcomes included ulcer healing rate, ulcer recurrence rate, ulcer-free time, anatomic vein closure, adverse events, adjunctive treatments, and changes in quality of life.

Results: The ulcer healing rate through the 24-month visit was 88.1%. The median time to healing was 92 days (95% CI: 74, 137). The recurrence rate through the 24-month visit was 22.9%. The mean ulcer free time through 24 months was 487.38±260.16 days. The probability of anatomic vein closure was 78.0% at 24 months. Adjudication of hypersensitivity, phlebitis, granuloma, and ablation-related thrombus extension revealed no device-related events after 6 months. Investigators used sub-ulcer sclerotherapy in 21.6% (27/125) of participants at the time of index procedures.

Conclusions: In patients with C6 disease treated with CAC, excellent ulcer healing rates and low ulcer recurrence rates were observed, and improvements in QoL and disease severity. This study demonstrates that CAC is an excellent and durable option for treatment of superficial venous reflux in patients with C6 disease.

Interim 6-month Results of the BERG02 Study: A Core Lab-Adjudicated Study of Percutaneous Ligation of Superficial and Perforator Veins Combined With Sclerotherapy Using a Novel Device
Presented by Steve Elias, MD

The single-center, nonrandomized BERG02 study evaluated the performance and safety of a percutaneous device for treating superficial and perforator vein incompetence. The VEnice device consists of a single-handed cannula preloaded with a permanent two-part clip connected by a suture. Under ultrasound guidance, the clip is implanted using a “thru and thru” ligation of the target vein in either longitudinal or transverse section. Foam sclerotherapy with 1% polidocanol in most cases was added for superficial veins; perforator veins were treated without foam.

The study enrolled 22 patients with symptomatic GSV incompetence and CEAP class C2 or higher. Mean age was 49.3 years, and 20 patients were women. Four vascular surgeons performed the procedures, three without prior device experience. Investigators treated 22 GSVs, three anterior saphenous veins, and 11 perforator veins. Mean proximal GSV diameter was 8.44 ± 2.57 mm.

The primary endpoint is complete closure of the treated extent of the GSV at 12 months, as defined by the core laboratory duplex ultrasound protocol. The primary safety endpoint is freedom from vascular-specific serious adverse events related to the device within 30 days.

Technical success was 100%, with deployment under ultrasound guidance in the transverse or longitudinal axis. The procedure was well tolerated, and deployment time was 1 to 2 minutes per clip. No device-related serious adverse events or procedure-related complications occurred within 30 days.

At 1 month, 22 of 22 GSVs and 10 of 11 perforator veins remained closed. Preliminary 6-month findings showed 100% closure in the eight patients with GSV results presented and in the three patients with perforator results presented. Core laboratory adjudication of occlusion at 1, 6, and 12 months is pending.

These interim findings support the safety and performance of percutaneous ligation of superficial and perforator veins with adjunctive sclerotherapy. Twelve-month follow-up will assess the durability of closure.

Early 30-Day Results From a Real-World Registry of the Abre Venous Stent System in Patients With Central Venous Disease
Presented by Paul Gagne, MD

Purpose: The Abre Venous Self-Expanding Stent System is indicated for treatment of symptomatic iliofemoral venous outflow obstruction. The purpose of this study is to evaluate the 30-day real-world safety and performance of the Abre stent.

Materials and Methods: The Medtronic Product Surveillance Registry (PSR; NCT01524276) is a prospective, global post-market surveillance platform. Between June 2024 and September 2025, 151 patients were enrolled (n=15 sites, Europe and USA), received at least one Abre stent, and were treated per routine care with planned five-year follow-up. The primary safety endpoint is freedom from stent fracture. The primary efficacy endpoint is the rate of target lesion revascularization (TLR). Both were assessed through 60 months. Secondary objectives include assessment of post-procedural pain, stent patency, and patient-reported health outcomes.

Results: Patients treated included 72.8% females (mean age 50.6 ± 17.4 years) treated for nonthrombotic iliac vein lesions (74.3%), post-thrombotic syndrome (21.1%), acute deep vein thrombosis (3.3%), and other (1.3%). Pelvic venous disorder (PeVD) was present in 45.7%. Procedures were performed per IFU (92.8%). The patient’s left limb was treated in 80.1%; mean disease length was 96.2 ± 77.6 mm; mean stented length was 150.5 ± 48.1 mm. All patients completed 30-day follow-up. Stent fractures (n=0) and TLR (n=1,0.7%) occurred through 30 days. Patients experienced significant pain decrease by 30 days. Higher baseline pain was associated with immediate greater post-procedure pain. Patients treated with larger stent diameters (18–20 mm) reported larger increases in immediate pain that decreased and aligned with the overall cohort by day 30.

Conclusion: This cohort had a high prevalence of nonthrombotic iliac vein lesions and stenting with the Abre venous stent showed favorable safety, low reintervention, and improvement in pain. Larger stent diameters (18–20 mm) had a greater increases in post-procedural pain which resolved by 30 days.

A Prospective Multicenter Trial of On-The-Table Mechanically Channeled Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism: Results of the Interim Analysis of 150 Participants in the RAPID-PE Study
Presented by Wissam A. Jaber, MD

Background: Catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism (PE) has conventionally required prolonged lytic infusion and monitoring. RAPID-PE evaluates on-the-table (OTT) mechanically channeled thrombolysis (MCT) using the THROMBOLEX® device without post-procedural lytic infusion.

Design: RAPID-PE is a prospective, multicenter, single-arm, open-label study enrolling up to 350 adults at up to 50 U.S. sites. Eligible patients have acute PE with computed tomography angiography (CTA) evidence of right ventricular dysfunction and dilatation. The expanded device basket creates channels within thrombus while delivering 4 targeted 1-mg dilute r-tPA pulse sprays per lung interspersed with saline flushes. The primary efficacy endpoint is all-cause mortality or hemodynamic decompensation through 7 days; the primary safety endpoint is International Society on Thrombosis and Haemostasis (ISTH) major bleeding, including intracranial hemorrhage.

Results: This preliminary interim analysis includes 150 participants. Mean age was 65.2 years, mean baseline RV/LV ratio was 1.40, and 140 (93.3%) had bilateral PE. The 7-day primary composite occurred in 1/150 (0.7%). Major bleeding within 72 hours occurred in 1/150 (0.7%). No ischemic or hemorrhagic strokes were reported through 30 days. Device- or procedure-related serious adverse events occurred in 2/150 (1.3%) through discharge. Post-treatment ICU care was provided to 15/150 patients (10.0%); 7/150 (4.7%) required ICU care due to their clinical condition. Within 30 days, recurrent PE occurred in 4/150 (2.7%) and rehospitalization in 17/150 (11.3%). Median hospital stay from emergency department arrival to discharge order was 2.96 days.

Conclusion: These preliminary single-arm findings show low observed rates of the primary composite and major bleeding following OTT MCT. Ninety percent had no post-treatment ICU stay. Enrollment continues toward 350 participants.

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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