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

NCT01113892 | Completed Results DMC FDA Device

• 1 other identifier: MCV00001506
• Study Type: interventional
• Target: 207
• Locations: 3 countries
• Sites: 25

Brief Summary

To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Participants With Primary Assisted Patency

  6 months

• Number of Participants With Secondary Patency

  6 months

• Time to Hemostasis of Suture Hole Bleeding (Min)

  Post-procedure

Other Outcomes (6)

• Number of Participants With Primary Patency

  30 days

• Number of Participants With Primary Patency

  12 months

• Number of Participants With Primary Assisted Patency

  30 days

Study Arms (2)

EXXCEL Soft

ACTIVE COMPARATOR

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

FUSION Bioline

EXPERIMENTAL

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

Interventions

vascular grafts DEVICE

All devices will be used to treat patients with peripheral arterial occlusive disease

EXXCEL Soft; FUSION Bioline

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maquet Cardiovascular: lead

Study Sites (25)

University of Alabama-Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location

Central Arkansas Veterans Health System

Little Rock, Arkansas, 72205, United States

Location

VA Palo Alto HCS

Palo Alto, California, 94304, United States

Location

University of South Florida - Tampa General

Tampa, Florida, 33606, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dartmouth- Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

NY Presbyterian Hospital - Columbia Univ Medical Center

New York, New York, 10032, United States

Location

Montefiore Weiler Hospital

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Central Texas Veterans Health System

Temple, Texas, 76504, United States

Location

Scott & White

Temple, Texas, 76508, United States

Location

Norfolk Sentara - Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Fakulti Nemocnice Brno

Brno, 625 00, Czechia

Location

Fakultni Nemocnice u sv Anny v Brno

Brno, 656 91, Czechia

Location

University Hospital Plzen

Pilsen, 304 60, Czechia

Location

Vseobecna Fakultni Nemocnice (VFN) Praha

Prague, 128 08, Czechia

Location

IKEM Praha

Prague, 140 21, Czechia

Location

Nemocnice Na Homolce

Prague, 150 30, Czechia

Location

Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Related Publications (2)

• 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.

  PMID: 25720929 BACKGROUND

• Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

  PMID: 41159585 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

Vascular Grafting

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

Follow-up period was limited to 12 months. The inner layer is identical to EXXCEL, but FUSION Bioline also has an external polyester layer in addition to the heparin coating. Choices in perioperative care (surgeon discretion) may have differed.

Results Point of Contact

• Title: Elizabeth Bulger
• Organization: Getinge Group

Elizabeth.Bulger@getinge.com

603 880 1433

Study Officials

• Alan Lumsden, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Nicholas J. Morrissey, MD

  NY Presbyterian-Columbia U Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This was a single-blind study. The surgeon and study site staff knew which vascular graft each subject received, but the subject did not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a prospective, randomized, single-blind (subject), parallel group, multicenter study in subjects with peripheral arterial occlusive disease (PAOD) who were scheduled to undergo femoral popliteal peripheral bypass surgery. Eligible subjects were randomly assigned in a 1:1 ratio to receive either FUSION Bioline or EXXCEL vascular graft.

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: May 17, 2010
• Primary Completion: December 18, 2012
• Study Completion: June 4, 2013
• Last Updated: May 22, 2020
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (18); CZ (6); DE (1)