Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05811364

The GORE VBX FORWARD Clinical Study: Comparing the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Complex Iliac Occlusive Disease

Led by W.L.Gore & Associates · Updated on 2026-05-13

244

Participants Needed

43

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying a device called the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to treat people with complex iliac occlusive disease, a condition affecting blood flow in the iliac arteries. This clinical trial is designed to compare this device to bare metal stenting, aiming to see which approach better keeps the arteries open over time. The study is prospective, multicenter, randomized, and controlled with a double masking design. Participants will be randomly assigned to one of two groups: one receiving the GORE VIABAHN VBX device and the other receiving a commercially available bare metal stent approved for this condition. Treatments focus on the common and/or external iliac arteries with lesions between 4 and 11 cm and vessel diameters between 5 mm and 13 mm. Both groups will receive stenting procedures using these devices. During the trial, participants will undergo evaluations to measure artery openness (primary patency) at one year and up to five years. Additional measures include technical and clinical success of procedures, hemodynamic status, quality of life changes, freedom from restenosis and revascularization, amputation-free survival, and overall survival. The study involves follow-up visits over several years to monitor these outcomes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at time of informed consent
  • Signed informed consent form
  • Ability to comply with protocol requirements including follow-up
  • Symptoms of claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
  • De novo or restenotic lesion(s) in the common and/or external iliac artery(ies)
  • Unilateral or bilateral lesions (>50% stenosis or chronic total occlusion) each 4 to 11 cm in length
  • Target vessel diameter approximately between 5 mm and 13 mm
  • Sufficient common femoral artery and at least one femoral artery (<50% stenotic)
  • At least one sufficient infrapopliteal run-off vessel (<50% stenotic)
Not Eligible

You will not qualify if you...

  • Life expectancy less than 1 year
  • Pregnancy at time of informed consent
  • Known allergy to stent or stent graft materials including nitinol, stainless steel, or heparin
  • Severe chronic renal insufficiency (serum creatinine > 2.5 mg/dL) without hemodialysis
  • Evidence of systemic infection
  • Known intolerance to antithrombotic medications preventing compliance
  • Vascular catheterization of lower extremities within 30 days prior to randomization (except diagnostic angiograms for study)
  • Previous stenting in the iliac arteries
  • Previous surgical bypass in the target limb
  • Participation in another investigative clinical study without sponsor approval
  • Lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or ablative device for stent delivery
  • Presence of abdominal aortic artery lesion or aneurysm
  • Lesion requiring stent placement within 2 cm of the inguinal ligament
  • Isolated common iliac artery stenosis treatable with a single device without kissing stents or extension into external iliac artery
  • Outflow disease requiring additional interventions such as common femoral endarterectomy or femoral/tibial revascularization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Procedure day

Participants receive stenting treatment of the common and/or external iliac arteries using either the GORE VIABAHN VBX Balloon Expandable Endoprosthesis or a commercially available bare metal stent.

1 procedure visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for clinical success, hemodynamic status, patency, and other outcomes through 5 years after treatment.

Periodic follow-up visits over 5 years

Trial Site Locations

Total: 43 locations

1

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States, 72205

Withdrawn

2

VA Long Beach Healthcare System

Long Beach, California, United States, 90822

Actively Recruiting

3

Denver Health and Hospital Authority

Denver, Colorado, United States, 80204

Actively Recruiting

4

North Suburban Medical Center

Denver, Colorado, United States, 80229

Withdrawn

5

University of Florida - Gainesville

Gainesville, Florida, United States, 32608

Actively Recruiting

6

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, United States, 33801

Actively Recruiting

7

University of South Florida

Tampa, Florida, United States, 33620

Actively Recruiting

8

Atlanta VA Medical Center

Decatur, Georgia, United States, 30033

Actively Recruiting

9

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States, 70112

Actively Recruiting

10

Beth Israel Deaconess Medical Center, Inc.

Boston, Massachusetts, United States, 02215

Actively Recruiting

11

Corewell Health System

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

12

The Curators of the University of Missouri

Columbia, Missouri, United States, 65212

Actively Recruiting

13

Research Foundation SUNY Buffalo

Amherst, New York, United States, 14228

Withdrawn

14

Trinity Medical Center

Buffalo, New York, United States, 14214

Actively Recruiting

15

VA Western New York Healthcare System

Buffalo, New York, United States, 14215

Actively Recruiting

16

New York University School of Medicine

New York, New York, United States, 10016

Actively Recruiting

17

Mt. Sinai Medical Center

New York, New York, United States, 10029

Actively Recruiting

18

Atrium Health

Charlotte, North Carolina, United States, 28210

Actively Recruiting

19

University Hospitals - Cleveland Medical Center

Ashland, Ohio, United States, 44805

Actively Recruiting

20

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

21

Portland Health Care System VA

Portland, Oregon, United States, 97239

Actively Recruiting

22

Providence Heart & Vascular Institute

Wilsonville, Oregon, United States, 97070

Actively Recruiting

23

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

24

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States, 37660

Actively Recruiting

25

The University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

26

Sentara Medical Group

Norfolk, Virginia, United States, 23507

Actively Recruiting

27

Central Adelaide Local Health Network Incorporated

Adelaide, Australia

Actively Recruiting

28

Royal Perth Hospital

Nedlands, Australia

Actively Recruiting

29

Prince of Wales Hospital

Randwick, Australia

Actively Recruiting

30

Universitats-Herzzentrum Freiburg Bad Krozingen GmbH

Bad Krozingen, Germany

Actively Recruiting

31

St. Franziskus Hospital

Münster, Germany

Actively Recruiting

32

Krankenhaus der Barmherzigen Brüder

Regensburg, Germany

Actively Recruiting

33

Klinikum Stuttgart

Stuttgart, Germany

Actively Recruiting

34

Ospedale Niguarda Ca'Granda

Milan, MI, Italy

Actively Recruiting

35

Ospedale Santa Maria della Misericordia

Perugia, Italy

Actively Recruiting

36

Azienda Complesso Ospedaliero San Filippo Neri

Roma, Italy

Actively Recruiting

37

Ospedale San Giovanni Molinette

Turin, Italy

Actively Recruiting

38

Rijnstate Hospital

Arnhem, Netherlands

Actively Recruiting

39

Stichting Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

Actively Recruiting

40

Auckland City Hospital

Auckland, New Zealand

Actively Recruiting

41

East Kent Hospitals University NHS Foundation Trust

Canterbury, United Kingdom

Actively Recruiting

42

Guy's and St Thomas', NHS Foundation Trust

London, United Kingdom

Actively Recruiting

43

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Actively Recruiting

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Research Team

A

Alexander Ambrocik

E

Enoque Costa

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

FORWARD Study of GORE VIABAHN Balloon-Expandable Endoprostheses and Bare Metal Stents in the United States, European Union, United Kingdom, Australia, and New Zealand When Placed to Treat Complex Iliac Occlusive Disease: Protocol for a Randomized Superiority Trial.

Melissa L Kirkwood, Ehrin J Armstrong, Mohammad M Ansari...

https://pubmed.ncbi.nlm.nih.gov/38048145