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Aortoiliac Occlusive DiseaseNCT05811364

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

A study testing Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent in people with Aortoiliac Occlusive Disease and Peripheral Arterial Disease, run by W.L.Gore & Associates at 43 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
244 participants
Where
43 sitesin 7 countries
Study dates
17 Oct 2023to 31 Jan 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • Life expectancy <1 year
  • Patient is pregnant at time of informed consent.
  • Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
  • Patient has severe chronic renal insufficiency (serum creatinine level > 2.5mg/dL) and not undergoing hemodialysis.
  • Patient has evidence of a systemic infection.
  • Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
Show all 15Show fewer
  • Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
  • Patient has previous stenting in the iliac arteries.
  • Patient has previous surgical bypass in the target limb.
  • Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.
  • Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.
  • Patient has an abdominal aortic artery lesion or aneurysm.
  • Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.
  • Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).
  • Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).

Trial locations and contacts

43 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Alexander Ambrocik contact

337-387-4954

aambroc@wlgore.com

Enoque Costa contact

928-525-4044

ecosta@wlgore.com

43 sites in 7 countries

United States26 sites, 23 recruiting

  • Research Foundation SUNY Buffalo

    Amherst, New York, 14228

    Withdrawn

  • University Hospitals - Cleveland Medical Center

    Ashland, Ohio, 44805

    Yulanka Castro-Dominguez, MD

    Recruiting

  • Beth Israel Deaconess Medical Center, Inc.

    Boston, Massachusetts, 02215

    Mark Wyers, MD

    Recruiting

  • Trinity Medical Center

    Buffalo, New York, 14214

    Aimee Swartz, MD

    Recruiting

  • VA Western New York Healthcare System

    Buffalo, New York, 14215

    Hasan Dosluoglu, MD

    Recruiting

  • Atrium Health

    Charlotte, North Carolina, 28210

    Hector Crespo-Soto, MD

    Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

    Levester Kirksey, MD

    Recruiting

  • The Curators of the University of Missouri

    Columbia, Missouri, 65212

    Jonathan Bath, MD

    Recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Melissa Kirkwood, MD

    Recruiting

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

    Olamine Alabi, MD

    Recruiting

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

    Lisa Bennett, MD

    Recruiting

  • North Suburban Medical Center

    Denver, Colorado, 80229

    Withdrawn

  • University of Florida - Gainesville

    Gainesville, Florida, 32608

    Samir Shah, MD

    Recruiting

  • Corewell Health System

    Grand Rapids, Michigan, 49503

    Andrew Kimball, MD

    Recruiting

  • Wellmont Holston Valley Medical Center

    Kingsport, Tennessee, 37660

    Christopher Metzger, MD

    Recruiting

  • Radiology and Imaging Specialists of Lakeland

    Lakeland, Florida, 33801

    Fakhir Elmasri, MD

    Recruiting

  • Central Arkansas Veterans Healthcare System

    Little Rock, Arkansas, 72205

    Withdrawn

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

    Anthony Chau, MD

    Recruiting

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70112

    Malachi Sheahan, MD

    Recruiting

  • New York University School of Medicine

    New York, New York, 10016

    Karan Garg, MD

    Recruiting

  • Mt. Sinai Medical Center

    New York, New York, 10029

    Prakash Krishnan, MD

    Recruiting

  • Sentara Medical Group

    Norfolk, Virginia, 23507

    David Dexter, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Grace Wang, MD

    Recruiting

  • Portland Health Care System VA

    Portland, Oregon, 97239

    Harish Krishnamoorthi, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33620

    Sashi Inkollu, MD

    Recruiting

  • Providence Heart & Vascular Institute

    Wilsonville, Oregon, 97070

    Brant Ullery, MD

    Recruiting

Other trials in United States

Germany4 sites, 4 recruiting

  • Universitats-Herzzentrum Freiburg Bad Krozingen GmbH

    Bad Krozingen

    Thomas Zeller, MD

    Recruiting

  • St. Franziskus Hospital

    Münster

    Martin Austermann, MD

    Recruiting

  • Krankenhaus der Barmherzigen Brüder

    Regensburg

    Markus Steinbauer, MD

    Recruiting

  • Klinikum Stuttgart

    Stuttgart

    Philipp Geisbusch, MD

    Recruiting

Other trials in Germany

Italy4 sites, 4 recruiting

  • Ospedale Niguarda Ca'Granda

    Milan, MI

    Valerio Tolva, MD

    Recruiting

  • Ospedale Santa Maria della Misericordia

    Perugia

    Paolo Frigatti, MD

    Recruiting

  • Azienda Complesso Ospedaliero San Filippo Neri

    Roma

    Sonia Ronchey, MD

    Recruiting

  • Ospedale San Giovanni Molinette

    Turin

    Andrea Discalzi, MD

    Recruiting

Other trials in Italy

Australia3 sites, 3 recruiting

  • Central Adelaide Local Health Network Incorporated

    Adelaide

    Conor Marron, MD

    Recruiting

  • Royal Perth Hospital

    Nedlands

    Nishath Altaf, MD

    Recruiting

  • Prince of Wales Hospital

    Randwick

    Ramon Varcoe, MD

    Recruiting

Other trials in Australia

United Kingdom3 sites, 3 recruiting

  • East Kent Hospitals University NHS Foundation Trust

    Canterbury

    Sandeep Bahia, MD

    Recruiting

  • Guy's and St Thomas', NHS Foundation Trust

    London

    Ashish Patel, MD

    Recruiting

  • University Hospital Southampton NHS Foundation Trust

    Southampton

    Mohammed Hadi

    Recruiting

Other trials in United Kingdom

Netherlands2 sites, 2 recruiting

  • Rijnstate Hospital

    Arnhem

    Michel Reijnen, MD

    Recruiting

  • Stichting Elisabeth-TweeSteden Ziekenhuis

    Tilburg

    Jan Heyligers, MD

    Recruiting

Other trials in Netherlands

New Zealand1 site, 1 recruiting

  • Auckland City Hospital

    Auckland

    Andrew Holden, MD

    Recruiting

Other trials in New Zealand

About this study

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.

Being tested
Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisDevice

    Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

  • Stenting of the Common and/or External Iliac Arteries with Bare Metal StentDevice

    Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.

Study groups in NCT05811364
Study groupRoleWhat they receive
VBX Device GroupActive comparatorSubject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
Receives: Device: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
BMS Control GroupActive comparatorSubjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease
Receives: Device: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Patency

    Blood flow through the target lesion (no evidence of binary restenosis >50% or occlusion) without a Target Lesion Revascularization (TLR).

    Measured: 1 year

Secondary outcomes (16)

  1. Technical success

    Deployment of device with < 30% residual stenosis on final angiography.

    Measured: at the procedure

  2. Acute procedural success

    Binary assessment based on technical success and freedom from device or procedure-related serious adverse events (SAE) requiring intervention.

    Measured: at the procedure

  3. Clinical success

    Improvement from baseline of at least 1 Rutherford Category and freedom from device or procedure-related SAE requiring intervention.

    Measured: Through 1 month

  4. Hemodynamic Status

    Change in Ankle-brachial index (ABI)/toe-brachial index (TBI) as compared to baseline

    Measured: Through 5 years

  5. Change in EQ-5D-5L

    Change in EQ-5D-5L responses as compared to baseline. The EQ-5D-5L Questionnaire measures quality of life (QoL) over 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is measured over five levels from no problems to extreme problems. Scored on a 0 to 100 scale with 0 as the worst possible health and 100 is the best possible health.

    Measured: Through 5 years

  6. Change in WIQ

    Change in Walking Impairment Questionnaire (WIQ) responses as compared to baseline. The WIQ is a validated QoL measurement of walking abilities over 3 dimensions: distance, speed, and stair-climbing. Scored on a 0 to 100 scale with 0 as no degree of difficulty and 100 is the highest degree of difficulty.

    Measured: Through 5 years

  7. Primary patency

    Blood flow through the target lesion (no evidence of binary restenosis >50% or occlusion) without a Target Lesion Revascularization (TLR).

    Measured: Through 5 years

  8. Freedom from binary restenosis

    Freedom from binary restenosis. binary restenosis defined as evidence of >50% restenosis or occlusion of the target lesion(s) based on core lab adjudicated duplex ultrasound or angiography

    Measured: Through 5 years

  9. Primary assisted patency

    Blood flow maintained (no evidence of occlusion) through the target lesion with or without a Target Lesion Revascularization (TLR).

    Measured: Through 5 years

  10. Secondary patency

    Blood flow through the target lesion with or without a Target Lesion Revascularization (TLR).

    Measured: Through 5 years

  11. Freedom from target lesion revascularization

    Freedom from target lesion revascularization (TLR). TLR defined as endovascular or surgical intervention performed on the target lesion(s).

    Measured: Through 5 years

  12. Cumulative reintervention rate

    Rate of first and recurrent Target Lesion Revascularization (TLR).

    Measured: Through 5 years

  13. Freedom from clinically driven target lesion revascularization

    Freedom from clinically driven target lesion revascularization. Endovascular or surgical intervention performed on the target lesion(s) in response to recurrent symptoms (increase ≥ 1 Rutherford Category).

    Measured: Through 5 years

  14. Amputation-free survival

    Binary assessment based on freedom from major amputation (target limb, amputation above the metatarsals) and all-cause mortality

    Measured: Through 5 years

  15. Survival

    Freedom from all-cause mortality

    Measured: Through 5 years

  16. Change in Rutherford Category

    Change in Rutherford Category as compared to baseline. Scaled from 0 to 6, with 0 as asymptotic and 6 as major tissue loss, extending above the transmetatarsal (TM) level, functional foot no longer salvageable.

    Measured: Through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start17 Oct 2023
  3. Primary completion30 Mar 2028 (estimated)
  4. Study completion31 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subject randomized to a VBX device group and BMS control group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
244 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05811364
Sponsor's protocol ID
VBX 22-06
Status last verified
May 2026
First submitted
14 Mar 2023
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Kirkwood ML, Armstrong EJ, Ansari MM, Holden A, Reijnen MMPJ, Steinbauer M, Crannell Z, Novoa H, Phillips A, Schneider DB. 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. JMIR Res Protoc. 2023 Dec 4;12:e51480. doi: 10.2196/51480.

    PubMed 38048145

Questions about this trial

What is this clinical trial studying?

A study testing Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent in people with Aortoiliac Occlusive Disease and Peripheral Arterial Disease, run by W.L.Gore & Associates at 43 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, Germany, Italy, Australia, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Ambrocik (337-387-4954, aambroc@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Patency (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05811364, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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