Study Comparing Synthetic Vascular Grafts in Patients With Peripheral Artery Disease (PAD) Who Require Artery Bypass.
- Conditions
- Peripheral Arterial Occlusive Disease
- Interventions
- Device: vascular grafts
- Registration Number
- NCT01113892
- Lead Sponsor
- Maquet Cardiovascular
- Brief Summary
To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 207
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EXXCEL Soft vascular grafts 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). FUSION Bioline vascular grafts 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Primary Patency 6 months 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).
The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD) 6 months 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Primary Assisted Patency 6 months 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 to Hemostasis of Suture Hole Bleeding (Min) Post-procedure Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes.
Number of Participants With Secondary Patency 6 months Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion.
Trial Locations
- Locations (25)
Montefiore Weiler Hospital
🇺🇸Bronx, New York, United States
IKEM Praha
🇨🇿Prague, Czechia
Central Texas Veterans Health System
🇺🇸Temple, Texas, United States
NYU School of Medicine
🇺🇸New York, New York, United States
Nemocnice Na Homolce
🇨🇿Prague, Czechia
Fakulti Nemocnice Brno
🇨🇿Brno, Czechia
Scott & White
🇺🇸Temple, Texas, United States
Norfolk Sentara - Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Fakultni Nemocnice u sv Anny v Brno
🇨🇿Brno, Czechia
Vseobecna Fakultni Nemocnice (VFN) Praha
🇨🇿Prague, Czechia
Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
NY Presbyterian Hospital - Columbia Univ Medical Center
🇺🇸New York, New York, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Central Arkansas Veterans Health System
🇺🇸Little Rock, Arkansas, United States
VA Palo Alto HCS
🇺🇸Palo Alto, California, United States
University Hospital Plzen
🇨🇿Plzen, Czechia
University of Alabama-Birmingham Medical Center
🇺🇸Birmingham, Alabama, United States
University of South Florida - Tampa General
🇺🇸Tampa, Florida, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Dartmouth- Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States