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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01113892
Recruitment Status : Completed
First Posted : April 30, 2010
Last Update Posted : January 16, 2014
Information provided by (Responsible Party):
Maquet Cardiovascular

April 28, 2010
April 30, 2010
January 16, 2014
April 2010
December 2012   (Final data collection date for primary outcome measure)
Primary Efficacy [ Time Frame: 6 months ]
Primary Patency
Primary patency [ Time Frame: 6 months ]
Efficacy - Primary patency at 6 months, assessed by Color-coded Duplex Ultrasound (i.e., a graft is considered to have "primary patency" if, from the time of implantation, it has remained continously patent)
Complete list of historical versions of study NCT01113892 on Archive Site
  • Secondary Efficacy [ Time Frame: 6 months ]
    • Primary assisted patency
    • Secondary patency
    • Suture hole bleeding at the time of graft implantation procedure
  • Safety [ Time Frame: Post-procedure, 30 days, 6 months, 12 months ]
    Safety endpoint is the composite of Major Adverse Limb Events and Periprocedural Deaths, including:
    • Major amputation
    • Major graft reintervention
    • Procedure-related death
Secondary Patency [ Time Frame: 12 months ]
Secondary patency (i.e., graft is considered to have "secondary patency" if it remains patent after some form of intervention to restore and maintain patency.) Suture line bleeding
Not Provided
Not Provided
Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.
Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)
To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline. The investigators expect the performance of the grafts to be similar.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Peripheral Arterial Occlusive Disease
Device: vascular grafts
All devices will be used to treat patients with peripheral arterial occlusive disease
  • Active Comparator: EXXCEL Soft
    Intervention: Device: vascular grafts
  • Experimental: FUSION Bioline
    Intervention: Device: vascular grafts
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. Erratum in: J Vasc Surg. 2015 May;61(5):1382.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient requires either above-knee or below-knee femoral popliteal bypass;
  • Patient has Category 1, 2, 3 4 or 5 chronic limb ischemia as defined by the Rutherford Categories - chronic limb ischemia severity classification scale.
  • Patient is at least 21 years of age;
  • Patient has postoperative life expectancy of >18 months;
  • Patient is willing and able to provide written, informed consent.

Exclusion Criteria:

  • Patient has a previous history of bypass in the diseased extremity (below iliacs);
  • 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 has active infection in the region of graft placement;
  • Patient has an acute arterial occlusion requiring an emergent intervention;
  • Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
  • Patient has known hypersensitivity or contraindication to aspirin;
  • Patient has known coagulation disorders including hypercoagulability;
  • Patient has previous instance of Heparin induced Thrombocytopenia type 2 or has known hypersensitivity to heparin;
  • Patient has severe chronic renal insufficiency, is undergoing hemodialysis. or has prior renal transplant;
  • Patient had a stroke or MI within 6 weeks of the procedure;
  • Patient is a woman of reproductive potential.
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Germany,   United States
Not Provided
Not Provided
Maquet Cardiovascular
Maquet Cardiovascular
Not Provided
Principal Investigator: Alan Lumsden, MD The Methodist Hospital System
Principal Investigator: Nicholas J. Morrissey, MD NY Presbyterian-Columbia U Medical Center
Maquet Cardiovascular
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP