Stent Placement Clinical Trials

Clinical trials related to Stent Placement Procedure

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Status: Recruiting
Location: See all (43) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

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

• Age ≥ 18 years at time of informed consent signature

• Informed Consent Form (ICF) is signed by the subject

• Subject can comply with protocol requirements, including follow-up

• Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)

• Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies)

• Patient has: Unilateral or bilateral single or multiple lesions (\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length

• Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm

• Patient has a sufficient (\<50% stenotic) common femoral artery and at least one sufficient (\<50% stenotic) femoral artery (deep or superficial).

• Patient has at least one sufficient (\<50% stenotic) infrapopliteal run-off vessel.

Locations
United States
Arkansas
Central Arkansas Veterans Healthcare System
WITHDRAWN
Little Rock
California
VA Long Beach Healthcare System
RECRUITING
Long Beach
Colorado
Denver Health and Hospital Authority
RECRUITING
Denver
North Suburban Medical Center
WITHDRAWN
Denver
Florida
University of Florida - Gainesville
RECRUITING
Gainesville
Radiology and Imaging Specialists of Lakeland
RECRUITING
Lakeland
University of South Florida
RECRUITING
Tampa
Georgia
Atlanta VA Medical Center
RECRUITING
Decatur
Louisiana
Louisiana State University Health Sciences Center
RECRUITING
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center, Inc.
RECRUITING
Boston
Michigan
Corewell Health System
RECRUITING
Grand Rapids
Missouri
The Curators of the University of Missouri
RECRUITING
Columbia
North Carolina
Atrium Health
RECRUITING
Charlotte
New York
Research Foundation SUNY Buffalo
WITHDRAWN
Amherst
Trinity Medical Center
RECRUITING
Buffalo
VA Western New York Healthcare System
RECRUITING
Buffalo
Mt. Sinai Medical Center
RECRUITING
New York
New York University School of Medicine
RECRUITING
New York
Ohio
University Hospitals - Cleveland Medical Center
RECRUITING
Ashland
Cleveland Clinic Foundation
RECRUITING
Cleveland
Oregon
Portland Health Care System VA
RECRUITING
Portland
Providence Heart & Vascular Institute
RECRUITING
Wilsonville
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Wellmont Holston Valley Medical Center
RECRUITING
Kingsport
Texas
The University of Texas Southwestern Medical Center
RECRUITING
Dallas
Virginia
Sentara Medical Group
RECRUITING
Norfolk
Other Locations
Australia
Central Adelaide Local Health Network Incorporated
RECRUITING
Adelaide
Royal Perth Hospital
RECRUITING
Nedlands
Prince of Wales Hospital
RECRUITING
Randwick
Germany
Universitats-Herzzentrum Freiburg Bad Krozingen GmbH
RECRUITING
Bad Krozingen
St. Franziskus Hospital
RECRUITING
Münster
Krankenhaus der Barmherzigen Brüder
RECRUITING
Regensburg
Klinikum Stuttgart
RECRUITING
Stuttgart
Italy
Ospedale Niguarda Ca'Granda
RECRUITING
Milan
Ospedale Santa Maria della Misericordia
RECRUITING
Perugia
Azienda Complesso Ospedaliero San Filippo Neri
RECRUITING
Roma
Ospedale San Giovanni Molinette
RECRUITING
Turin
Netherlands
Rijnstate Hospital
RECRUITING
Arnhem
Stichting Elisabeth-TweeSteden Ziekenhuis
RECRUITING
Tilburg
New Zealand
Auckland City Hospital
RECRUITING
Auckland
United Kingdom
East Kent Hospitals University NHS Foundation Trust
RECRUITING
Canterbury
Guy's and St Thomas', NHS Foundation Trust
RECRUITING
London
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Contact Information
Primary
Alexander Ambrocik
aambroc@wlgore.com
337-387-4954
Backup
Enoque Costa
ecosta@wlgore.com
928-525-4044
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2032-01-31
Participants
Target number of participants: 244
Treatments
Active_comparator: VBX Device Group
Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Active_comparator: BMS Control Group
Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease
Sponsors
Leads: W.L.Gore & Associates

This content was sourced from clinicaltrials.gov