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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular
ClinicalTrials.gov Identifier:
NCT01113892
First received: April 28, 2010
Last updated: January 15, 2014
Last verified: January 2014

April 28, 2010
January 15, 2014
April 2010
December 2012   (final data collection date for primary outcome measure)
Primary Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Primary Patency
Primary patency [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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 ClinicalTrials.gov Archive Site
  • Secondary Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Peripheral Arterial Occlusive Disease
Device: vascular grafts
All devices will be used to treat patients with peripheral arterial occlusive disease
Other Name: vascular grafts
  • Active Comparator: EXXCEL Soft
    Intervention: Device: vascular grafts
  • Experimental: FUSION Bioline
    Intervention: Device: vascular grafts
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Czech Republic,   Germany
 
NCT01113892
MCV00001506
Yes
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