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

Completed · Not applicable

Conditions studied: Peripheral Arterial Occlusive Disease

In brief

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

Key facts

Study ID

NCT01113892

Run by

Maquet Cardiovascular

People needed

207

Starts

2010-05-17

Expected to finish

2013-06-04

Last updated by the study team

2020-05-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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