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

• ClinicalTrials.gov Identifier: NCT05811364
• Recruitment Status: Recruiting
• First Posted: April 13, 2023
• Last Update Posted: November 9, 2023
• Sponsor: W.L.Gore & Associates
• Information provided by (Responsible Party): W.L.Gore & Associates

Tracking Information

• First Submitted Date: March 14, 2023
• First Posted Date: April 13, 2023
• Last Update Posted Date: November 9, 2023
• Actual Study Start Date: October 17, 2023
• Estimated Primary Completion Date: April 30, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2023)

Primary Patency [ Time Frame: 1 year ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 30, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Official 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Subject randomized to a VBX device group and BMS control group

Masking: Double (Participant, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Treatment

Condition

• Aortoiliac Occlusive Disease
• Peripheral Arterial Disease

Intervention

• 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.
• 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.

Study Arms

• Active Comparator: VBX Device Group
  Subject in this group will receive treatment with the GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
  Intervention: Device: Stenting of the Common and/or External Iliac Arteries 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
  Intervention: Device: Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 30, 2023): 244
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2031
• Estimated Primary Completion Date: April 30, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Makensley Lordeus; 623-234-5989; mlordeus@wlgore.com

• Listed Location Countries: Germany, Netherlands, New Zealand, United States

Administrative Information

• NCT Number: NCT05811364
• Other Study ID Numbers: VBX 22-06
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: W.L.Gore & Associates
• Original Responsible Party: Same as current
• Current Study Sponsor: W.L.Gore & Associates
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: W.L.Gore & Associates
• Verification Date: November 2023