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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05811364
• Other study ID #: VBX 22-06
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: April 30, 2031

Study information

• Verified date: November 2023
• Source: W.L.Gore & Associates
• Contact: Makensley Lordeus
• Phone: 623-234-5989
• Email: mlordeus[@]wlgore.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 244
• Est. completion date: April 30, 2031
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aortoiliac Occlusive Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

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.
• 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.

Locations

Country	Name	City	State
Germany	Krankenhaus der Barmherzigen Brüder	Regensburg
Netherlands	Rijnstate Hospital	Arnhem
New Zealand	Auckland City Hospital	Auckland
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	North Suburban Medical Center	Denver	Colorado
United States	Radiology and Imaging Specialists of Lakeland	Lakeland	Florida
United States	Texas Tech University Health Science Center	Lubbock	Texas
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Technical success	Deployment of device with < 30% residual stenosis on final angiography.	at the procedure
Secondary	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
Secondary	Clinical success	Improvement from baseline of at least 1 Rutherford Category and freedom from device or procedure-related SAE requiring intervention.	Through 1 month
Secondary	Hemodynamic Status	Change in Ankle-brachial index (ABI)/toe-brachial index (TBI) as compared to baseline	Through 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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	Secondary patency	Blood flow through the target lesion with or without a Target Lesion Revascularization (TLR).	Through 5 years
Secondary	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
Secondary	Cumulative reintervention rate	Rate of first and recurrent Target Lesion Revascularization (TLR).	Through 5 years
Secondary	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
Secondary	Amputation-free survival	Binary assessment based on freedom from major amputation (target limb, amputation above the metatarsals) and all-cause mortality	Through 5 years
Secondary	Survival	Freedom from all-cause mortality	Through 5 years
Secondary	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