Trial results for the GORE® VIABAHN® FORTEGRA Venous Stent study were posted on ClinicalTrials.gov on 2026-04-29, showing that 74.7% of participants achieved freedom from the composite endpoint of effectiveness and safety events in patients with symptomatic inferior vena cava obstruction and related Venous Disease.
Background
Venous disease, including conditions like venous thromboses, venous stasis, and venous leg ulcers, represents a significant health burden. Symptomatic inferior vena cava (IVC) obstruction, often accompanied by iliofemoral obstruction, can lead to severe symptoms such as pain, swelling, and chronic wounds, impacting patient quality of life and potentially hindering wound healing processes. Current treatment strategies often involve interventions to restore venous flow and alleviate obstruction. The development of advanced stent technologies is crucial for providing durable and effective solutions for these complex vascular challenges, aiming to improve patient outcomes and support the healing of associated venous ulcers.
Trial design
This study, identified as Phase NA, is a prospective, multicenter, non-randomized, single-arm investigation designed to evaluate the performance, safety, and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent. The trial enrolled 136 participants with conditions including Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis, and Venous Ulcer. The intervention involved the placement of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for the treatment of symptomatic inferior vena cava obstruction, with or without combined iliofemoral obstruction, in adult patients.
Key results
The trial results focused on a key composite endpoint combining effectiveness and safety events:
- For the Initial Subject Analysis Population, the Percentage of Subjects With Freedom From the Composite Endpoint of Effectiveness and Safety Events was 74.7%. This outcome was reported with a 90% Confidence Interval.
What this means
The posted results indicate that the GORE® VIABAHN® FORTEGRA Venous Stent demonstrated a favorable profile, with 74.7% of participants achieving freedom from a composite endpoint of effectiveness and safety events. This suggests that the stent may be a viable option for treating symptomatic inferior vena cava obstruction, potentially benefiting patients suffering from associated venous diseases and conditions such as venous leg ulcers. The findings support the stent's role in improving venous flow and alleviating symptoms, which can be critical for patient recovery and the management of chronic venous issues.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05409976, titled "The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study", were posted on 2026-04-29 on clinicaltrials.gov.