Clinical trial NCT01113892: Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.
Official title: Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: Maquet Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 207
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Primary Patency
timeFrame: 6 months
measure: The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD)
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Primary Assisted Patency
timeFrame: 6 months
measure: Number of Participants With Secondary Patency
timeFrame: 6 months
measure: Time to Hemostasis of Suture Hole Bleeding (Min)
timeFrame: Post-procedure
Other outcomes:
measure: Number of Participants With Primary Patency
timeFrame: 30 days
measure: Number of Participants With Primary Patency
timeFrame: 12 months
measure: Number of Participants With Primary Assisted Patency
timeFrame: 30 days
measure: Number of Participants With Primary Assisted Patency
timeFrame: 12 months
measure: Number of Participants With Secondary Patency
timeFrame: 30 days
measure: Number of Participants With Secondary Patency
timeFrame: 12 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama-Birmingham Medical Center
state: Alabama
city: Little Rock
country: United States
facility: Central Arkansas Veterans Health System
state: Arkansas
city: Palo Alto
country: United States
facility: VA Palo Alto HCS
state: California
city: Tampa
country: United States
facility: University of South Florida - Tampa General
state: Florida
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth- Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Weiler Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: NY Presbyterian Hospital - Columbia Univ Medical Center
state: New York
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Health System
state: Texas
city: Temple
country: United States
facility: Scott & White
state: Texas
city: Norfolk
country: United States
facility: Norfolk Sentara - Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Brno
country: Czechia
facility: Fakulti Nemocnice Brno
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv Anny v Brno
city: Plzen
country: Czechia
facility: University Hospital Plzen
city: Prague
country: Czechia
facility: Vseobecna Fakultni Nemocnice (VFN) Praha
city: Prague
country: Czechia
facility: IKEM Praha
city: Prague
country: Czechia
facility: Nemocnice Na Homolce
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Alan Lumsden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NY Presbyterian-Columbia U Medical Center
name: Nicholas J. Morrissey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.