Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction
W.L.Gore & Associates
Summary
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.
Description
A maximum of 30 clinical sites across the U.S. will participate in the study. One hundred and sixty-five subjects are intended to be implanted with the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) in this study, with a limit of 33 treated subjects per site. Subjects will be evaluated through hospital discharge and return for follow-up visits at 1, 6, 12, 24, 36, 48, and 60 months post-treatment.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Preoperative Inclusion Criteria: * Patient is at least 18 years of age. * Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen. * Patient is able to provide informed consent. * One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2. * Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent. * Estimated life expectancy ≥1 year. * Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable). * Patient has adequate inflow t…
Interventions
- DeviceGORE® VIAFORT Vascular Stent
Treatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.
Locations (27)
- Stanford University School of MedicineStanford, California
- Advanced Heart and Vein (ClinRe)Thornton, Colorado
- Vascular Care GroupDarien, Connecticut
- Yale UniversityNew Haven, Connecticut
- MedStar Washington Hospital CenterWashington D.C., District of Columbia
- Manatee Memorial HospitalBradenton, Florida