The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

Part of paid clinical trials in Stanford, California.

Sponsor
W.L.Gore & Associates
Study ID
NCT05489588
Status
Recruiting
Apply to this trial

Conditions

  • Vein Disease
  • Vein Occlusion
  • Vein Thrombosis
  • Venous Disease
  • Venous Leg Ulcer
  • Venous Occlusion
  • Venous Stasis
  • Venous Stenosis
  • Venous Thromboses
  • Venous Ulcer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GORE® VIAFORT Vascular Stent — DEVICE
    Treatment of unilateral symptomatic iliofemoral venous obstruction with the GORE® VIAFORT Vascular Stent.

Study Details

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.

Key Dates

Start date
Mar 2, 2023
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Mar 31, 2031

Study Design

Enrollment
165 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: GORE® VIAFORT Vascular Stent
    GORE® VIAFORT Vascular Stent

Primary Outcome Measure

Composite of safety events [ Time Frame: 12 months (Stent Embolization) or 30 days (all other components) ]

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305
Isabelle Schlegel
[email protected]
Andrew Kesselman, MD (PRINCIPAL_INVESTIGATOR)
Alex Vezeridis, MD (SUB_INVESTIGATOR)
Andrew Picel, MD (SUB_INVESTIGATOR)
William Kuo, MD (SUB_INVESTIGATOR)
Lawrence Hofmann, Md (SUB_INVESTIGATOR)
Mona Ranade, MD (SUB_INVESTIGATOR)
Advanced Heart and Vein (ClinRe)ThorntonColorado80023-
Vascular Care GroupDarienConnecticut06820
Liz Gagne
[email protected]
203-548-7860
Paul Gagne, MD (PRINCIPAL_INVESTIGATOR)
Edward Arous, MD (SUB_INVESTIGATOR)
Chong Li, MD (SUB_INVESTIGATOR)
Naiem Nassiri, MD (SUB_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06519
Sara Niesobecki
[email protected]
Cassius Chaar, MD (PRINCIPAL_INVESTIGATOR)
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Kassaye Sesaba
[email protected]
202-877-7452
Suman Singh
[email protected]
202-877-8475
Steven Abramowitz, MD (PRINCIPAL_INVESTIGATOR)
Kyle Reynolds, MD (SUB_INVESTIGATOR)
Misaki Kiguchi, MD (SUB_INVESTIGATOR)
Danielle Salazar, MD (SUB_INVESTIGATOR)
Saher Sabri, MD (SUB_INVESTIGATOR)
Manatee Memorial HospitalBradentonFlorida34208
Nicolette Weston
[email protected]
Santosh Jay Mathews, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Kristie Kennedy
[email protected]
Ramona Gupta, MD (SUB_INVESTIGATOR)
Kush Desai, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Kaitlin Gossart
[email protected]
Julianne Stoughton, MD (PRINCIPAL_INVESTIGATOR)
Luis Suarez, MD (SUB_INVESTIGATOR)
Abhisekh Mohapatra, MD (SUB_INVESTIGATOR)
Nikolaos Zacharias, MD (SUB_INVESTIGATOR)
Jahan Mohabeli, MD (SUB_INVESTIGATOR)
Vascular Care GroupWellesleyMassachusetts02482
Elizabeth Gagne
[email protected]
Todd Lancaster, MD (PRINCIPAL_INVESTIGATOR)
Daniel Gorin, MD (SUB_INVESTIGATOR)
Christopher Kwolek, MD (SUB_INVESTIGATOR)
Stratton Danes, MD (SUB_INVESTIGATOR)
Scott James, MD (SUB_INVESTIGATOR)
Elizabeth Blazick, MD (SUB_INVESTIGATOR)
University of Michigan HospitalAnn ArborMichigan48109
Safa Mohamed
[email protected]
William Sherk, MD (PRINCIPAL_INVESTIGATOR)
David Williams, MD (SUB_INVESTIGATOR)
Minhajuddin Khaja, MD (SUB_INVESTIGATOR)
Amber Liles, MD (SUB_INVESTIGATOR)
Daniel Kirkpatrick, MD (SUB_INVESTIGATOR)
Englewood Hospital & Med CenterEnglewoodNew Jersey07631
Taylor Doublin
[email protected]
Steven Elias, MD (PRINCIPAL_INVESTIGATOR)
Holy Name Medical CenterTeaneckNew Jersey07666-
Mount Sinai Medical CenterNew YorkNew York10029
Jack Waitz
[email protected]
973-274-5838
Windsor Ting, MD (PRINCIPAL_INVESTIGATOR)
Ajit Rao, MD (SUB_INVESTIGATOR)
Stony BrookStony BrookNew York11790
Victoria Boufis
[email protected]
631-444-8156
Andrew Bryan
[email protected]
631-444-8156
Angela Kokkosis, MD (PRINCIPAL_INVESTIGATOR)
Apostolos Tassiopoulos, MD (SUB_INVESTIGATOR)
St. Peter's Vascular AssociatesTroyNew York12180
Spencer Phelps
[email protected]
Kathleen Ozsvath, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina - Chapel HillChapel HillNorth Carolina27599
Shivani Amin
[email protected]
Rebekah Roten
[email protected]
919-843-1278
Katharine McGinigle, MD (PRINCIPAL_INVESTIGATOR)
William Marston, MD (SUB_INVESTIGATOR)
Nicole Keefe, MD (SUB_INVESTIGATOR)
Atrium Health-Sanger Heart and Vascular InstituteCharlotteNorth Carolina28204
Dana Amaro
[email protected]
704-355-4692
Erin Murphy, MD (PRINCIPAL_INVESTIGATOR)
Frank Arko, MD (SUB_INVESTIGATOR)
Hector Crespo-Soto, MD (SUB_INVESTIGATOR)
NC Heart and Vascular ResearchRaleighNorth Carolina27519
Karime Assaf
[email protected]
Robert Mendes, MD (PRINCIPAL_INVESTIGATOR)
Jason Kim, MD (SUB_INVESTIGATOR)
Martyn Knowles, MD (SUB_INVESTIGATOR)
Bethesda NorthCincinnatiOhio45242
Laurie Freel
[email protected]
Patrick Muck, MD (PRINCIPAL_INVESTIGATOR)
Mark Broering, MD (SUB_INVESTIGATOR)
Adam Reichard, MD (SUB_INVESTIGATOR)
Aaron Kulwicki, MD (SUB_INVESTIGATOR)
Matt Recht, MD (SUB_INVESTIGATOR)
Cleveland Clinic FoundationClevelandOhio44195
Corinna Packard
[email protected]
Mary Alice Bowman
[email protected]
Jon Quatromoni, MD (PRINCIPAL_INVESTIGATOR)
Sean Lyden, MD (SUB_INVESTIGATOR)
Francis Caputo, MD (SUB_INVESTIGATOR)
Ali Khalifeh, MD (SUB_INVESTIGATOR)
Levester Kirksey, MD (SUB_INVESTIGATOR)
David Laczynski, MD (SUB_INVESTIGATOR)
University Hospitals ClevelandClevelandOhio44106
Janice Wolfe
[email protected]
216-844-2636
Karem Harth, MD (PRINCIPAL_INVESTIGATOR)
Yulanka Castro-Dominguez, MD (SUB_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania14213
Judith Brimmeier
[email protected]
412-623-8486
Julia Wozniak
[email protected]
Eric Hager, MD (SUB_INVESTIGATOR)
Nathan Liang, MD (SUB_INVESTIGATOR)
Natalie Sridharan, MD (PRINCIPAL_INVESTIGATOR)
Michael Singh, MD (SUB_INVESTIGATOR)
Raymond Eid, MD (SUB_INVESTIGATOR)
Theodore Yuo, MD (SUB_INVESTIGATOR)
The Miriam HospitalProvidenceRhode Island02906
Bailey Nevins
[email protected]
Peter Soukas, MD (SUB_INVESTIGATOR)
Pieter de Klerk, MD (PRINCIPAL_INVESTIGATOR)
UT SouthwesternDallasTexas75390
Jarret Hubbard
[email protected]
214-648-9449
Emma Bryant
[email protected]
Michael Siah, MD (PRINCIPAL_INVESTIGATOR)
Sentara General HospitalNorfolkVirginia23507
Sarah Havert
[email protected]
757-388-2991
David Dexter, MD (PRINCIPAL_INVESTIGATOR)
Overlake HospitalBellevueWashington98004
Kathleen Gibson, MD (PRINCIPAL_INVESTIGATOR)
Elica Inagaki, MD (SUB_INVESTIGATOR)
Renee Minjarez, MD (SUB_INVESTIGATOR)
Sooyeon Kim, MD (SUB_INVESTIGATOR)
Medical College of Wisconsin - Froedtert HospitalMilwaukeeWisconsin53226
Kelly Salinas
[email protected]
414-805-4709
Helena Zaldivar Alcantara
[email protected]
Parag Patel, MD (PRINCIPAL_INVESTIGATOR)
Matthew Scheidt, MD (SUB_INVESTIGATOR)
Eric Hohenwalter, MD (SUB_INVESTIGATOR)
Mustafa Haddad, MD (SUB_INVESTIGATOR)
Kalla Tremblay, MD (SUB_INVESTIGATOR)

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