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

Peripheral Arterial Occlusive Disease Clinical Trial

— FINEST  

Official title:

Comparison of Safety and Primary Patency Between FUSION Vascular Graft With Bioline and EXXCEL Soft ePTFE (FINEST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113892
• Other study ID #: MCV00001506
• Status: Completed
• Phase: N/A
• Start date: May 17, 2010
• Est. completion date: June 4, 2013

Study information

• Verified date: May 2020
• Source: Maquet Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 4, 2013
• Est. primary completion date: December 18, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Occlusive Disease

Intervention

Device:
• vascular grafts
All devices will be used to treat patients with peripheral arterial occlusive disease

Locations

Country	Name	City	State
Czechia	Fakulti Nemocnice Brno	Brno
Czechia	Fakultni Nemocnice u sv Anny v Brno	Brno
Czechia	University Hospital Plzen	Plzen
Czechia	IKEM Praha	Prague
Czechia	Nemocnice Na Homolce	Prague
Czechia	Vseobecna Fakultni Nemocnice (VFN) Praha	Prague
Germany	Klinikum Karlsruhe	Karlsruhe
United States	Albany Medical Center	Albany	New York
United States	University of Alabama-Birmingham Medical Center	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Montefiore Weiler Hospital	Bronx	New York
United States	Dallas VA Medical Center	Dallas	Texas
United States	Methodist Hospital	Houston	Texas
United States	Dartmouth- Hitchcock Medical Center	Lebanon	New Hampshire
United States	Central Arkansas Veterans Health System	Little Rock	Arkansas
United States	NY Presbyterian Hospital - Columbia Univ Medical Center	New York	New York
United States	NYU School of Medicine	New York	New York
United States	Norfolk Sentara - Norfolk General Hospital	Norfolk	Virginia
United States	VA Palo Alto HCS	Palo Alto	California
United States	Swedish Medical Center	Seattle	Washington
United States	University of South Florida - Tampa General	Tampa	Florida
United States	Central Texas Veterans Health System	Temple	Texas
United States	Scott & White	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Maquet Cardiovascular

Countries where clinical trial is conducted

United States,  Czechia,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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