To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
207
All devices will be used to treat patients with peripheral arterial occlusive disease
University of Alabama-Birmingham Medical Center
Birmingham, Alabama, United States
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).
Time frame: 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.
Time frame: 6 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.
Time frame: 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.
Time frame: 6 months
Time to Hemostasis of Suture Hole Bleeding (Min)
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Central Arkansas Veterans Health System
Little Rock, Arkansas, United States
VA Palo Alto HCS
Palo Alto, California, United States
University of South Florida - Tampa General
Tampa, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dartmouth- Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical Center
Albany, New York, United States
NYU School of Medicine
New York, New York, United States
NY Presbyterian Hospital - Columbia Univ Medical Center
New York, New York, United States
...and 15 more locations
Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes.
Time frame: Post-procedure