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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
244
Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
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.
North Suburban Medical Center
Denver, Colorado, United States
RECRUITINGRadiology and Imaging Specialists of Lakeland
Lakeland, Florida, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
Primary Patency
Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).
Time frame: 1 year
Technical success
Deployment of device with \< 30% residual stenosis on final angiography.
Time frame: 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.
Time frame: at the procedure
Clinical success
Improvement from baseline of at least 1 Rutherford Category and freedom from device or procedure-related SAE requiring intervention.
Time frame: Through 1 month
Hemodynamic Status
Change in Ankle-brachial index (ABI)/toe-brachial index (TBI) as compared to baseline
Time frame: 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.
Time frame: 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.
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The University of Texas Southwestern Medical Center
Dallas, Texas, United States
NOT_YET_RECRUITINGKrankenhaus der Barmherzigen Brüder
Regensburg, Germany
RECRUITINGRijnstate Hospital
Arnhem, Netherlands
RECRUITINGAuckland City Hospital
Auckland, New Zealand
RECRUITINGTime frame: 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).
Time frame: 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
Time frame: 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).
Time frame: Through 5 years
Secondary patency
Blood flow through the target lesion with or without a Target Lesion Revascularization (TLR).
Time frame: 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).
Time frame: Through 5 years
Cumulative reintervention rate
Rate of first and recurrent Target Lesion Revascularization (TLR).
Time frame: 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).
Time frame: Through 5 years
Amputation-free survival
Binary assessment based on freedom from major amputation (target limb, amputation above the metatarsals) and all-cause mortality
Time frame: Through 5 years
Survival
Freedom from all-cause mortality
Time frame: 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.
Time frame: Through 5 years