NCT05811364

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
70mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
4 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Oct 2023Jan 2032

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2028

Expected
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2032

Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

4.5 years

First QC Date

March 14, 2023

Last Update Submit

April 11, 2025

Conditions

Aortoiliac Occlusive DiseasePeripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

  • Primary Patency

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

    1 year

Secondary Outcomes (16)

  • Technical success

    at the procedure

  • Acute procedural success

    at the procedure

  • Clinical success

    Through 1 month

  • Hemodynamic Status

    Through 5 years

  • Change in EQ-5D-5L

    Through 5 years

  • +11 more secondary outcomes

Study Arms (2)

VBX Device Group

ACTIVE COMPARATOR

Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)

Device: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

BMS Control Group

ACTIVE COMPARATOR

Subjects in this group will receive treatment with a commercially available bare metal stent (BMS) that is approved for treatment of the disease

Device: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

Interventions

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.

VBX Device Group
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.

BMS Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

North Suburban Medical Center

Denver, Colorado, 80229, United States

RECRUITING

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, 33801, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

Krankenhaus der Barmherzigen Brüder

Regensburg, Germany

RECRUITING

Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

Auckland City Hospital

Auckland, New Zealand

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38048145DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Central Study Contacts

Makensley Lordeus

CONTACT

623-234-5989mlordeus@wlgore.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Every effort will be made to blind subjects to the treatment device up to the 1 year follow up visit. The independent Core Lab and Clinical Events Committee (CEC) members will also be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subject randomized to a VBX device group and BMS control group
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 13, 2023

Study Start

October 17, 2023

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

January 31, 2032

Last Updated

April 16, 2025

Record last verified: 2025-04

Locations

NL(1)DE(1)US(4)NZ(1)