Late-Breaking Clinical Trial Results Announced at The VEINS 2025

LAS VEGAS, Nov. 2, 2025 /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 2025 conference, held at Wynn Las Vegas.

Late-Breaking Clinical Trial results were unveiled during sessions on Saturday and Sunday, November 1 and 2, showcasing new data that advance the understanding and treatment of venous disease.

The VEINS (Venous Endovascular INterventional Strategies) is a leading venous education symposium that brings together an international, multispecialty faculty to share the latest research, clinical data, and techniques in venous intervention. The program features expert presentations, interactive discussions, and data-driven sessions that inform best practices and foster collaboration across the venous community.

Results of the GORE^® VIABAHN^® FORTEGRA Venous Stent Clinical Trial for the Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction
Presented by Stephen Black, MD

The presentation entitled "Results of the GORE^® VIABAHN^® FORTEGRA Venous Stent Clinical Trial for the Treatment of Symptomatic Inferior Vena Cava Obstruction With or Without Combined Iliofemoral Obstruction" exhibits promising results from the GORE^® VIAFORT Vascular Stent Trial, evaluating the newly renamed GORE^® VIABAHN^® FORTEGRA Venous Stent for the treatment of deep venous obstruction.

Presented by Co-Primary Investigator Dr. Stephen Black, MD, at the VEINS Conference in Las Vegas on November 2, the trial evaluates the device's safety and effectiveness in patients with symptomatic deep venous disease. The trial met its primary endpoint, demonstrating strong 12-month performance and reliability, reinforcing Gore's commitment to advancing innovative solutions for complex venous conditions.

The VIAFORT Trial is the first prospective study to include the inferior vena cava (IVC), iliac, and femoral veins. Conducted across multiple international centers, the single-arm, non-randomized trial enrolled 89 patients with thrombotic disease—acute, subacute, or chronic/post-thrombotic syndrome. Notably, 94.3% of patients had lesions spanning three vessel regions, and 68.5% required stents extending below the inguinal ligament into the common femoral vein.

Despite the severity of disease, the trial achieved a 12-month primary patency rate of 83.4%. Vessel-specific patency rates were 96.5% in the IVC, 88.9% in the left iliofemoral, and 89.8% in the right iliofemoral regions. No stent migrations, fractures, vascular injuries, or clinically significant pulmonary embolisms were reported through 12 months. Additionally, there were no device-related deaths or major bleeding events within 30 days.

These results mark a significant milestone in venous stent innovation and patient care, positioning the GORE^® VIABAHN^® FORTEGRA Venous Stent as a reliable option for treating deep venous obstruction.

Randomized Comparison of Cyanoacrylate Closure and Endothermal Ablation: Spectrum Secondary Outcomes Through 12 Months
Presented by Manj Gohel, MD

This randomized trial was part of the Spectrum program and compared cyano­acrylate closure (CAC) with the VenaSeal system (Medtronic) to endothermal abla­tion (ETA) for saphenous reflux. Conducted at 17 sites across eight countries, the study enrolled participants with CEAP (clinical, etiology, anatomy, pathophysiology) C2 to C5 disease beginning in February 2020. Outcomes at 12 months included anatomic vein closure, patient and physician assess­ments of quality of life (QOL), safety, time to return to work, and reintervention rates.

Differences in QOL changes from base­line to follow-up visits were tested using Wilcoxon two-sample tests. Anatomic closure at 12 months was calculated with Kaplan-Meier estimates, and reintervention rates were estimated using the number of reinterventions over the target vein follow-up years. No adjustments for multiple com­parisons were made for the QOL outcome tests comparing ETA and CAC, and statistical significance was not claimed for any P values.

At 7 days, improvement in the revised Venous Clinical Severity Score trended in favor of CAC (−2.2 ± 2.76) over ETA (−1.4 ± 2.51; P = .0037), and scores were compa­rable at 12 months (−3.9 ± 2.70 vs −3.8 ± 2.93; P = .8421). The Aberdeen Varicose Vein Questionnaire also trended in favor of CAC at 30 days (−5.4 ± 7.88 vs −2.5 ± 8.19; P = .0072) and was similar at 12 months (−8.0 ± 7.68 vs −6.6 ± 10.37; P = .0641). Vein occlusion rates through 12 months were similar between CAC (86.6%) and ETA (89.3%). No new device- or procedure-relat­ed safety events were recorded between 6 and 12 months. Hypersensitivity to CAC occurred in 5.9% (8/136) of participants, mostly self-limiting. Exit site granuloma occurred in 0.7% (one patient in the CAC group, with full resolution), and phlebitis occurred in 8.8% (CAC) versus 2.9% (ETA) patients. Ablation-related thrombus exten­sion occurred in 0.7% (CAC) and 3.6% (ETA). Serious adverse events were rare, with none related to CAC.

Participants treated with CAC showed similar improvements in QOL to ETA. Most CAC-related safety events happen in the first 6 months after intervention. CAC is a suitable alternative to the standard of care for patients with superficial venous insufficiency.

Clinical Feasibility and Safety Study of the Use of a Novel Device for the Treatment of Chronic Venous Insufficiency of the Lower Limb
Presented by Steve Elias, MD

A nonrandomized, prospective, single-center study (Salus Spitali in Tirana, Albania) enrolled 28 patients with varicose disease of the lower limbs who underwent great saphenous vein (GSV) occlusion using a novel percutaneous device deployed under ultrasound and ablation using polidocanol foam.

The primary endpoint assessed the feasibility and safety of the GSV occlusion procedure with the device, in combina­tion with ultrasound-guided foam sclero­therapy. Safety was determined by moni­toring serious adverse events related to the device within 30 days postprocedure. Feasibility was determined by completion of GSV occlusion at the end of the pro­cedure, documented with intraoperative duplex ultrasound showing absence of any flow inside the vessel.

Secondary endpoints included GSV occlusion rates at 6 and 12 months; pro­cedural complication rates assessed at dis­charge, 1 week, and 1, 6, and 12 months; assessment of pain (visual analog scale) at discharge and at 1 week; change in dis­ease-specific quality of life (QOL) at 6 and 12 months; and change in CEAP (clinical, etiology, anatomy, pathophysiology) class at 6 and 12 months.

Results demonstrated a 100% technical success rate for deployment under ultra­sound guidance, with all treated vessels occluded at the end of the procedure. The procedure was well tolerated, with no device-related adverse events. One patient experienced subfascial calf venous throm­bosis at 1 week, which resolved after 10 days of heparin therapy. Preliminary follow-up data showed durable occlusion rates: GSV/small saphenous vein occlu­sion was achieved in 92.3% of cases at 6 months and 94.1% at 12 months; perfo­rator occlusion was 84% at 6 months and 90% at 12 months. Patients also reported significant improvement in QOL.

Impact of Junctional Reflux on the Effectiveness of Endovenous Ablation in Patients With Great Saphenous Vein Insufficiency (JURY-2 Study) 
Presented by: Yana Etkin, MD

Isolated great saphenous vein (GSV) reflux without saphenofemoral junction (SFJ) involvement produces symptom sever­ity comparable to limbs with combined SFJ plus GSV reflux, and yet many insurers still require documented SFJ reflux before approving ablation. The JURY-2 trial was designed to evaluate whether symptomatic improvement after endovenous ablation is equivalent in patients with isolated GSV reflux versus those with combined SFJ plus GSV reflux.

This prospective, multicenter cohort study enrolled adults with symptomatic CEAP (clinical, etiology, anatomy, patho­physiology) C2 to C3 venous disease and ≥ 0.5 seconds of reflux in at least two con­tiguous, above-knee GSV segments (with or without SFJ reflux). Patients underwent thermal or nonthermal GSV ablation with adjunct phlebectomy or sclerotherapy as needed. Symptom severity was measured by Venous Clinical Severity Score (VCSS) at baseline and 3 months postprocedure. The primary endpoint was change in VCSS, compared between groups using Welch two-sample t-tests and multivariable linear regression, adjusting for baseline VCSS and demographic/clinical covariates. Treatment outcomes were considered equivalent if the VCSS change difference was within ± 1.4 points (minimum detectable change).

Nine United States centers enrolled 252 patients (207 SFJ + GSV, 45 isolated GSV). Most were female (75%) and White (78.6%). Patients with isolated reflux were older (aged 59 vs 53 years; P = .006) and more frequently Hispanic (13.3% vs 6.3%; P < .01). Thermal ablation was used in 73% overall, more often in the combined group (77.8% vs 57.8%; P = .01). GSV closure exceeded 99% without complications. Baseline VCSS was 6.98 ± 2.24 (isolated) compared to 6.00 ± 2.16 (com­bined) (P = .01). At 3 months, VCSS improved to 2.58 ± 2.60 and 1.71 ± 1.87, respectively. Adjusted VCSS change scores were equivalent (–0.54 [90% CI, –1.36 to 0.27]; P = .12).

Endovenous ablation yields equivalent short-term symptom relief in limbs with iso­lated GSV reflux and those with combined SFJ + GSV reflux. These findings challenge reimbursement policies mandating SFJ involvement and support basing treatment eligibility based on clinical need rather than junctional anatomy.

Short-Term Cost Effectiveness of Large-Bore Mechanical Thrombectomy vs Catheter-Directed Thrombolysis for Intermediate-Risk Pulmonary Embolism From the PEERLESS Randomized Controlled Trial 
Presented by: Samuel Horr, MD

The PEERLESS randomized controlled trial (RCT) provided clinical data through 30-day follow-up comparing large-bore mechanical thrombectomy (LBMT) and catheter-directed thrombolysis (CDT) for intermediate-risk pulmonary embolism (PE), but the economic implications of these outcomes remain unquantified. This study leverages findings from the PEERLESS RCT and other published lit­erature to evaluate the short-term cost-effectiveness of LBMT versus CDT within the United States health care system.

A decision tree model simulated the clinical pathways and associated costs for a hypothetical cohort of 300,000 intermediate-risk PE patients over a 30-day period. Clinical event prob­abilities and resource utilization were derived from the PEERLESS RCT, while costs and quality-of-life utilities were sourced from existing literature. The primary outcomes included total costs, quality-adjusted life-years (QALYs), and net monetary benefit (NMB).

The base-case analysis demonstrated that LBMT was economically dominant, being both more effective and less costly than CDT. On a per-patient basis, treat­ment with LBMT was associated with an average cost savings of $4,755 and a gain of 0.009 QALYs. These savings were pri­marily driven by substantial reductions in intensive care unit utilization (–$6,454), the avoidance of thrombolytic drugs (–$4,068), shorter overall hospital stays (–$2,217), and fewer readmissions (–$1,134). These dif­ferences in cost and effectiveness result in an NMB of $5,211 at a willingness-to-pay threshold of $50,000/QALY. Probabilistic sensitivity analysis confirmed the robust­ness of this conclusion, with LBMT remain­ing the economically dominant strategy in 87.8% of simulations.

This economic analysis makes a strong case that for patients with intermediate-risk PE undergoing intervention, the selection of LBMT over CDT represents high economic value, resulting in both improved patient outcomes and lower total 30-day health care costs.

Comparison of Real-World Outcomes in Pulmonary Embolism Patients Undergoing Large Bore Mechanical Thrombectomy or Receiving Anticoagulation  Alone: Insights From the Premier Healthcare Database
Presented by: Jay Giri, MD, MPH

Although anticoagulation (AC) is the cor­nerstone of pulmonary embolism (PE) treat­ment, large-bore mechanical thrombectomy (LBMT) may confer additional benefits via rapid thrombus removal. Large-scale ran­domized evidence comparing LBMT treat­ment to AC alone is currently lacking. This observational study aims to address this evi­dence gap by comparing patient characteris­tics and short-term outcomes of PE patients who received either LBMT or AC alone from a large, real-world health care database.

This analysis utilized the Premier Healthcare Database, which captures approximately 25% of all inpatient dis­charges in the United States. We identified patients presenting with PE or with prima­ry diagnosis of PE who underwent LBMT with the FlowTriever system (Inari Medical, now part of Stryker) (n = 5,613) or received AC alone (n = 202,199) between January 2019 and December 2023. Outcomes were statistically adjusted for demographic information, signs of acute PE severity, and standard comorbidities.

Before adjustment, LBMT patients showed signs of greater PE severity while patients receiving AC alone had a higher prevalence of chronic comorbidities. Following adjustment, LBMT was asso­ciated with significantly lower odds of in-hospital all-cause mortality (odds ratio [OR], 0.37; CI, 0.30-0.47; P < .001) and 30-day all-cause readmission (OR, 0.64; CI, 0.57-0.72; P < .001). Although associ­ated intensive care unit (ICU) admission was more frequent in the LBMT group (OR, 5.87; CI, 5.54-6.22; P < .001), LBMT patients had a briefer associated ICU length of stay (estimate, –0.48 days; CI, –0.59 to –0.37; P < .001) among those with admissions.

This large real-world analysis indi­cates that acute PE patients selected for treatment with LBMT may experience improved short-term outcomes compared with those treated with AC alone. These findings justify the critical importance of actively enrolling randomized trials of acute PE intervention, including PEERLESS II.

Two-Year Clinical Outcomes From the Single-Arm Arteriovenous Graft Cohort of the WAVE Trial 
Presented by: Mahmood Razavi, MD

The WAVE study is a prospective, mul­ticenter, international trial conducted across 43 centers in the United States, South America, and the United Kingdom. This abstract focuses on the nonrandom­ized arm of the trial that included a single cohort of patients with an arteriovenous graft (AVG) who experienced venous outflow obstructions in their periph­eral venous outflow circuit. All patients were treated with the Wrapsody Cell- Impermeable Endoprosthesis (CIE; Merit Medical Systems, Inc.). Treatment efficacy was based on the proportion of patients with target lesion primary patency (TLPP), defined as freedom from clinically driven target lesion revascularization or target lesion thrombosis. Access circuit primary patency (ACPP) was an additional efficacy measure of interest. The safety profile of the CIE was determined based on the proportion of patients without any local­ized or systemic safety events. Efficacy and safety results were reported throughout the 24-month follow-up period. At key time points, the efficacy and safety profiles of the CIE were compared to performance goals (6-month TLPP benchmark, 60%; 30-day safety benchmark, 89%).

A total of 112 AVG patients were enrolled. The 6-month TLPP was sig­nificantly higher than the efficacy perfor­mance goal (81.4% vs 60%; P < .0001). The proportion of patients in the AVG cohort without a safety event was significantly higher than the safety performance goal (95.4% vs 89%; P = .016). At 12 months, the TLPP was 60.2%, based on Kaplan- Meier estimate. The 6- and 12-month ACPP were 69.2% and 36.2%, respectively.

Given the limited treatment options available to restore access circuit patency, particularly for patients with dysfunction­al AVG, the 24-month findings from the WAVE trial will be of interest to vascular access specialists.

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/.

SOURCE The VIVA Foundation