Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass. (FINEST)

Maquet

Status: Completed

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Device: vascular grafts

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113892

MCV00001506

Details and patient eligibility

About

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.

Full description

The study is a prospective, randomized, single-blind, two-arm, parallel group, multi-center study to evaluate the safety and efficacy of FUSION™ Vascular Graft with Bioline (heparin) coating, compared with EXXCEL Soft ePTFE in a peripheral bypass setting, to support a claim of substantial equivalence.

Enrollment: 207 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient required either above-knee or below-knee femoral popliteal bypass;
• Patient had Category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the Rutherford Categories - chronic limb ischemia severity classification scale.
• Patient was at least 21 years of age;
• Patient had postoperative life expectancy of >18 months;
• Patient was willing and able to have follow-up visits and examinations;
• Patient would not participate in other clinical trials that would conflict with this protocol
• Patient was willing and able to provide written, informed consent.

Exclusion criteria

• Patient had a previous history of bypass in the diseased extremity (below the iliacs arteries);
• Patient had percutaneous transluminal angioplasty or stenting of the target femoral or popliteal artery at the anticipated site of the proximal or distal anastomosis within the previous 30 days;
• Patient had active infection in the region of graft placement;
• Patient had an acute arterial occlusion requiring an emergent intervention;
• Patient needed a cardiac surgical procedure or a different vascular surgical procedure within 30 days of planned lower extremity revascularization. Planned endovascular procedures to address proximal stenotic lesions at the time of the index femoropopliteal bypass did not exclude a patient from the study;
• Patient required sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
• Patient had known hypersensitivity or contraindication to aspirin;
• Patient had known coagulation disorders including hypercoagulability;
• Patient had previous instance of heparin-induced thrombocytopenia type 2 or has known hypersensitivity to heparin; Patient was currently treated with Coumadin (warfarin) that had not been stopped within 72 hours of the planned procedure
• Patient had severe chronic renal insufficiency (plasma/serum creatinine > 2.5 mg/dl), is undergoing hemodialysis.
• Patient had prior renal transplant;
• Patient had a stroke or myocardial infarction within 6 weeks of the procedure or had evidence of prior massive stroke (Modified Rankin Scale 3 or above);
• Patient had a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris;
• Patient had documented acute or suspected systemic infection;
• Patient was a woman of reproductive potential.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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207 participants in 2 patient groups

EXXCEL Soft

Active Comparator group

Description:

A vascular graft comprised of extruded, expanded polytetrafluroethylene (ePTFE), indicated for use as a vascular prosthesis for replacement or bypass of diseased peripheral arteries (510(k) K962433).

Treatment:

Device: vascular grafts

FUSION Bioline

Experimental group

Description:

A synthetic vascular graft constructed of two layers. The inner layer is comprised of extruded, ePTFE. The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate-urethane adhesive. The vascular graft also has a heparin coating on the graft's luminal surface. The Bioline coating is a bioactive surface coating consisting of a covalent Heparin Sodium coupled to immobilized recombinant human albumin.

Treatment:

Device: vascular grafts