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
  Purpose

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline. The investigators expect the performance of the grafts to be similar.


Condition Intervention
Peripheral Arterial Occlusive Disease
Device: vascular grafts

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)

Resource links provided by NLM:


Further study details as provided by Maquet Cardiovascular:

Primary Outcome Measures:
  • Primary Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Primary Patency


Secondary Outcome Measures:
  • 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


Enrollment: 207
Study Start Date: April 2010
Study Completion Date: October 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EXXCEL Soft Device: vascular grafts
All devices will be used to treat patients with peripheral arterial occlusive disease
Other Name: vascular grafts
Experimental: FUSION Bioline Device: vascular grafts
All devices will be used to treat patients with peripheral arterial occlusive disease
Other Name: vascular grafts

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01113892

  Show 28 Study Locations
Sponsors and Collaborators
Maquet Cardiovascular
Investigators
Principal Investigator: Alan Lumsden, MD The Methodist Hospital System
Principal Investigator: Nicholas J. Morrissey, MD NY Presbyterian-Columbia U Medical Center
  More Information

No publications provided

Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01113892     History of Changes
Other Study ID Numbers: MCV00001506
Study First Received: April 28, 2010
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014