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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 625 00
    • Fakulti nemocnice Brno
  • Brno, Czechia, 656 91
    • Fakultni Nemocnice u sv Anny v Brno
  • Plzen, Czechia, 304 60
    • University Hospital Plzen
  • Prague, Czechia, 150 30
    • Nemocnice Na Homolce
  • Prague, Czechia, 128 08
    • Vseobecna Fakultni Nemocnice (VFN) Praha
  • Prague, Czechia, 140 21
    • IKEM Praha
• Germany
  • Karlsruhe, Germany, 76133
    • Klinikum Karlsruhe
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama-Birmingham Medical Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Veterans Health System
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto HCS
  • Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida - Tampa General
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth- Hitchcock Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Montefiore Weiler Hospital
    • New York, New York, United States, 10016
      • NYU School of Medicine
    • New York, New York, United States, 10032
      • NY Presbyterian Hospital - Columbia Univ Medical Center
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • Houston, Texas, United States, 77030
      • Methodist Hospital
    • Temple, Texas, United States, 76504
      • Central Texas Veterans Health System
    • Temple, Texas, United States, 76508
      • Scott & White
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Norfolk Sentara - Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: EXXCEL Soft; A vascular graft comprised of extruded, expanded polytetrafluroethylene (ePTFE), indicated for use as a vascular prosthesis for replacement or bypass of diseased peripheral arteries (510(k) K962433).	Device: vascular grafts; All devices will be used to treat patients with peripheral arterial occlusive disease
EXPERIMENTAL: FUSION Bioline; A synthetic vascular graft constructed of two layers. The inner layer is comprised of extruded, ePTFE. The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate-urethane adhesive. The vascular graft also has a heparin coating on the graft's luminal surface. The Bioline coating is a bioactive surface coating consisting of a covalent Heparin Sodium coupled to immobilized recombinant human albumin.	Device: vascular grafts; All devices will be used to treat patients with peripheral arterial occlusive disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Primary Patency	A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. Assessed by duplex ultrasound imaging and ankle brachial index (ABI).	6 months
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD)	The composite endpoint included any of the following: Major amputation - amputation that resulted in limb shortening (e.g., proximal to, but not including transmetatarsal amputations);; Major graft reintervention - placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision, or graft thrombolysis;; Procedure-related death - any death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomic site or as a result of the index procedure.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Primary Assisted Patency	Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft.	6 months
Number of Participants With Secondary Patency	Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.	6 months
Time to Hemostasis of Suture Hole Bleeding (Min)	Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes.	Post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Primary Patency	A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency.	30 days
Number of Participants With Primary Patency	A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency.	12 months
Number of Participants With Primary Assisted Patency	Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft.	30 days
Number of Participants With Primary Assisted Patency	Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft.	12 months
Number of Participants With Secondary Patency	Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.	30 days
Number of Participants With Secondary Patency	Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.	12 months

Collaborators and Investigators

• Sponsor: Maquet Cardiovascular
• Investigators: Principal Investigator: Alan Lumsden, MD, The Methodist Hospital Research Institute; Principal Investigator: Nicholas J. Morrissey, MD, NY Presbyterian-Columbia U Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2010
• Primary Completion (ACTUAL): December 18, 2012
• Study Completion (ACTUAL): June 4, 2013

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (ESTIMATE): April 30, 2010

Study Record Updates

• Last Update Posted (ACTUAL): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: MCV00001506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes