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

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Aortoiliac Occlusive Disease
• Intervention / Treatment: Device: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis; Device: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Makensley Lordeus; Phone Number: 623-234-5989; Email: mlordeus@wlgore.com

Study Locations

• Germany
  • Regensburg, Germany
    • Not yet recruiting
    • Krankenhaus der Barmherzigen Brüder
    • Contact: Markus Steinbauer, MD
• Netherlands
  • Arnhem, Netherlands
    • Not yet recruiting
    • Rijnstate hospital
    • Contact: Michel Reijnen, MD
• New Zealand
  • Auckland, New Zealand
    • Not yet recruiting
    • Auckland City Hospital
    • Contact: Andrew Holden, MD
• United States
  • Colorado
    • Denver, Colorado, United States, 80229
      • Not yet recruiting
      • North Suburban Medical Center
      • Contact: Ehrin Armstrong, MD
  • Florida
    • Lakeland, Florida, United States, 33801
      • Recruiting
      • Radiology and Imaging Specialists of Lakeland
      • Contact: Fakhir Elmasri, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Not yet recruiting
      • University of Pennsylvania
      • Contact: Darren Schneider, MD
  • Texas
    • Dallas, Texas, United States, 75390
      • Not yet recruiting
      • The University of Texas Southwestern Medical Center
      • Contact: Melissa Kirkwood, MD
    • Lubbock, Texas, United States, 79430
      • Not yet recruiting
      • Texas Tech University Health Science Center
      • Contact: Mac Ansari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VBX Device Group; 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; Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
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	Device: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Deployment of device with < 30% residual stenosis on final angiography.	at the procedure
Acute procedural success	Binary assessment based on technical success and freedom from device or procedure-related serious adverse events (SAE) requiring intervention.	at the procedure
Clinical success	Improvement from baseline of at least 1 Rutherford Category and freedom from device or procedure-related SAE requiring intervention.	Through 1 month
Hemodynamic Status	Change in Ankle-brachial index (ABI)/toe-brachial index (TBI) as compared to baseline	Through 5 years
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.	Through 5 years
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.	Through 5 years
Primary patency	Blood flow through the target lesion (no evidence of binary restenosis >50% or occlusion) without a Target Lesion Revascularization (TLR).	Through 5 years
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	Through 5 years
Primary assisted patency	Blood flow maintained (no evidence of occlusion) through the target lesion with or without a Target Lesion Revascularization (TLR).	Through 5 years
Secondary patency	Blood flow through the target lesion with or without a Target Lesion Revascularization (TLR).	Through 5 years
Freedom from target lesion revascularization	Freedom from target lesion revascularization (TLR). TLR defined as endovascular or surgical intervention performed on the target lesion(s).	Through 5 years
Cumulative reintervention rate	Rate of first and recurrent Target Lesion Revascularization (TLR).	Through 5 years
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).	Through 5 years
Amputation-free survival	Binary assessment based on freedom from major amputation (target limb, amputation above the metatarsals) and all-cause mortality	Through 5 years
Survival	Freedom from all-cause mortality	Through 5 years
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.	Through 5 years

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2031

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: VBX 22-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes