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

NCT ID: NCT01113892

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-17
• Study Completion Date: 2013-06-04

Brief Summary

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

Detailed 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.

Conditions

Peripheral Arterial Occlusive Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EXXCEL Soft

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).

Group Type: ACTIVE_COMPARATOR

vascular grafts

Intervention Type: DEVICE

All devices will be used to treat patients with peripheral arterial occlusive disease

FUSION Bioline

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.

Group Type: EXPERIMENTAL

vascular grafts

Intervention Type: DEVICE

All devices will be used to treat patients with peripheral arterial occlusive disease

Interventions

vascular grafts

All devices will be used to treat patients with peripheral arterial occlusive disease

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maquet Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Lumsden, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Nicholas J. Morrissey, MD

Role: PRINCIPAL_INVESTIGATOR

NY Presbyterian-Columbia U Medical Center

Locations

University of Alabama-Birmingham Medical Center

Birmingham, Alabama, United States

Central Arkansas Veterans Health System

Little Rock, Arkansas, United States

VA Palo Alto HCS

Palo Alto, California, United States

University of South Florida - Tampa General

Tampa, Florida, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dartmouth- Hitchcock Medical Center

Lebanon, New Hampshire, United States

Albany Medical Center

Albany, New York, United States

NYU School of Medicine

New York, New York, United States

NY Presbyterian Hospital - Columbia Univ Medical Center

New York, New York, United States

Montefiore Weiler Hospital

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Dallas VA Medical Center

Dallas, Texas, United States

Methodist Hospital

Houston, Texas, United States

Central Texas Veterans Health System

Temple, Texas, United States

Scott & White

Temple, Texas, United States

Norfolk Sentara - Norfolk General Hospital

Norfolk, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Fakulti Nemocnice Brno

Brno, , Czechia

Fakultni Nemocnice u sv Anny v Brno

Brno, , Czechia

University Hospital Plzen

Pilsen, , Czechia

Vseobecna Fakultni Nemocnice (VFN) Praha

Prague, , Czechia

IKEM Praha

Prague, , Czechia

Nemocnice Na Homolce

Prague, , Czechia

Klinikum Karlsruhe

Karlsruhe, , Germany

Countries

United States; Czechia; Germany

References

Lumsden AB, Morrissey NJ; Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE (FINEST) Trial Co-investigators. Randomized controlled trial comparing the safety and efficacy between the FUSION BIOLINE heparin-coated vascular graft and the standard expanded polytetrafluoroethylene graft for femoropopliteal bypass. J Vasc Surg. 2015 Mar;61(3):703-12.e1. doi: 10.1016/j.jvs.2014.10.008.

Reference Type: BACKGROUND

PMID: 25720929 (View on PubMed)

Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10:CD015022. doi: 10.1002/14651858.CD015022.pub2.

Reference Type: DERIVED

PMID: 41159585 (View on PubMed)

Other Identifiers

MCV00001506

Identifier Type: -

Identifier Source: org_study_id