Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.

• Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.

• Presence of non-malignant unilateral obstruction of the common femoral vein, external iliac vein, and/or common iliac vein defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram.

• Patient can accommodate an appropriately sized GORE® VIAFORT Vascular Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.

• Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.

• Patient has adequate landing zones free from significant disease requiring treatment within the native vessels beyond the proximal and distal margins of the lesion.

• Patient has adequate inflow to the target lesion(s), per investigator/sub-investigator discretion, involving at least a patent femoral or deep femoral vein.

• Lesion can be traversed with a guidewire.

• Disease involves only unilateral iliofemoral venous segments with intent to stent all affected iliofemoral segments. Patients with disease extending into the inferior vena cava or contra-lateral iliofemoral veins who are anticipated to require endovascular or surgical treatment within 12 months after investigational device implant will be excluded.

• Patient does not have significant (i.e., \>20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with ≤20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.

Locations
United States
California
Stanford University School of Medicine
RECRUITING
Stanford
Colorado
Advanced Heart and Vein (ClinRe)
WITHDRAWN
Thornton
Connecticut
Vascular Care Group
RECRUITING
Darien
Yale University
RECRUITING
New Haven
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Florida
Manatee Memorial Hospital
RECRUITING
Bradenton
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Vascular Care Group
RECRUITING
Wellesley
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
North Carolina
University of North Carolina - Chapel Hill
RECRUITING
Chapel Hill
Atrium Health-Sanger Heart and Vascular Institute
RECRUITING
Charlotte
NC Heart and Vascular Research
RECRUITING
Raleigh
New Jersey
Englewood Hospital & Med Center
RECRUITING
Englewood
Holy Name Medical Center
WITHDRAWN
Teaneck
New York
Mount Sinai Medical Center
RECRUITING
New York
Stony Brook
RECRUITING
Stony Brook
St. Peter's Vascular Associates
RECRUITING
Troy
Ohio
Bethesda North
RECRUITING
Cincinnati
Cleveland Clinic Foundation
RECRUITING
Cleveland
University Hospitals Cleveland
RECRUITING
Cleveland
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Rhode Island
The Miriam Hospital
RECRUITING
Providence
Texas
UT Southwestern
RECRUITING
Dallas
Virginia
Sentara General Hospital
RECRUITING
Norfolk
Washington
Overlake Hospital
RECRUITING
Bellevue
Wisconsin
Medical College of Wisconsin - Froedtert Hospital
RECRUITING
Milwaukee
Contact Information
Primary
Carl Conway
cconway@wlgore.com
6175952277
Backup
Leonard Resecker
lresecke@wlgore.com
62356520649287074940
Time Frame
Start Date: 2023-03-02
Estimated Completion Date: 2031-03
Participants
Target number of participants: 165
Treatments
Experimental: GORE® VIAFORT Vascular Stent
GORE® VIAFORT Vascular Stent
Sponsors
Leads: W.L.Gore & Associates

This content was sourced from clinicaltrials.gov