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

Study Overview
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Brief Summary
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To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.

Detailed Description
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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.

Official Title
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Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)

Conditions
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Peripheral Arterial Occlusive Disease

Intervention / Treatment
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* Device: vascular grafts


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This was a prospective, randomized, single-blind (subject), parallel group, multicenter study in subjects with peripheral arterial occlusive disease (PAOD) who were scheduled to undergo femoral popliteal peripheral bypass surgery. Eligible subjects were randomly assigned in a 1:1 ratio to receive either FUSION Bioline or EXXCEL vascular graft.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EXXCEL Soft<br>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). | Device: vascular grafts<br>* All devices will be used to treat patients with peripheral arterial occlusive disease<br>|
| Experimental: FUSION Bioline<br>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. | Device: vascular grafts<br>* All devices will be used to treat patients with peripheral arterial occlusive disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Primary Patency | A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. Assessed by duplex ultrasound imaging and ankle brachial index (ABI). | 6 months | 
| The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD) | The composite endpoint included any of the following: Major amputation - amputation that resulted in limb shortening (e.g., proximal to, but not including transmetatarsal amputations); Major graft reintervention - placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision, or graft thrombolysis; Procedure-related death - any death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomic site or as a result of the index procedure. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Primary Assisted Patency | Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft. | 6 months | 
| Number of Participants With Secondary Patency | Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion. | 6 months | 
| Time to Hemostasis of Suture Hole Bleeding (Min) | Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes. | Post-procedure |