Clinical trial NCT05811364: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortoiliac Occlusive Disease
Peripheral Arterial Disease
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2023-04-13
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subject randomized to a VBX device group and BMS control group
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Primary Patency
timeFrame: 1 year
Secondary outcomes:
measure: Technical success
timeFrame: at the procedure
measure: Acute procedural success
timeFrame: at the procedure
measure: Clinical success
timeFrame: Through 1 month
measure: Hemodynamic Status
timeFrame: Through 5 years
measure: Change in EQ-5D-5L
timeFrame: Through 5 years
measure: Change in WIQ
timeFrame: Through 5 years
measure: Primary patency
timeFrame: Through 5 years
measure: Freedom from binary restenosis
timeFrame: Through 5 years
measure: Primary assisted patency
timeFrame: Through 5 years
measure: Secondary patency
timeFrame: Through 5 years
measure: Freedom from target lesion revascularization
timeFrame: Through 5 years
measure: Cumulative reintervention rate
timeFrame: Through 5 years
measure: Freedom from clinically driven target lesion revascularization
timeFrame: Through 5 years
measure: Amputation-free survival
timeFrame: Through 5 years
measure: Survival
timeFrame: Through 5 years
measure: Change in Rutherford Category
timeFrame: Through 5 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: North Suburban Medical Center
state: Colorado
city: Lakeland
country: United States
facility: Radiology and Imaging Specialists of Lakeland
state: Florida
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Regensburg
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
References: