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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama-Birmingham Medical Center
Birmingham, Alabama, United States, 35294
United States, Arkansas
Central Arkansas Veterans Health System
Little Rock, Arkansas, United States, 72205
United States, California
VA Palo Alto HCS
Palo Alto, California, United States, 94304
United States, Florida
University of South Florida Med Ctr
Tampa, Florida, United States, 33606
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, New Hampshire
Dartmouth- Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467
Montefiore Weiler Hospital
Bronx, New York, United States, 10461
NY Presbyterian Hosp - Columbia Univ Med Ctr
New York, New York, United States, 10032
NYU School of Medicine
New York, New York, United States, 10016
Cornell - NY Presbyterian
New York, New York, United States, 10065
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Methodist Hospital
Houston, Texas, United States, 77030
Central Texas Veterans Health System
Temple, Texas, United States, 76504
Scott & White
Temple, Texas, United States, 76508
United States, Virginia
Norfolk Sentara - Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Austria
Gefasschirurgisches Zentrum Wien, Wilhelminenspital
Vienna, Austria, A-1160
Czech Republic
Fakultni Nemocnice u sv Anny v Brno
Brno, Czech Republic, 656 91
Fakulti Nemocnice Brno
Brno, Czech Republic, 625 00
University Hospital Plzen
Plzen, Czech Republic, 304 60
IKEM Praha
Prague, Czech Republic, 140 21
Nemocnice Na Homolce
Prague, Czech Republic, 150 30
Vseobecna Fakultni Nemocnice (VFN)
Prague, Czech Republic, 128 08
Germany
Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Klinikum rechts der Isar Abteilung fur Gefasschirurgie
Munich, Germany, 81675
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 September 18, 2014