Clinical trial NCT01601496: Evaluation of FUSION™ Vascular Graft for Above Knee Targets
Official title: Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease (PAOD)
Lead sponsor: Maquet Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients treated with the FUSION Vascular Graft
Primary purpose: TREATMENT

Brief summary: The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.

Detailed description: This study was a prospective, single-arm, multicenter study conducted in Germany and Austria to evaluate the FUSION Vascular Graft in patients with peripheral arterial occlusive disease undergoing above-the-knee bypass. Follow-up visits were performed at 30 days, 6 months, 12 months and included patency and post operative complications not associated with bypass patency.

Eligibility criteria: Inclusion Criteria:

* No known malignant disease
* Patient was willing and able to have follow-up visits and examinations
* Peripheral arterial occlusive disease (PAOD) requiring treatment of the femoral artery; Fontaine stage IIb, III and IV with dry peripheral gangrene, and suitable for surgery
* Patient was not participating in other clinical trials that would conflict with this protocol
* Patient agreed to the study provisions and provided written informed consent

Exclusion Criteria:

* Urgent or emergent surgery of any kind
* Documented acute or suspected systemic infection
* Life expectancy of less than one year
* Patients who had a minor or major stroke within 6 weeks of the procedure or who had evidence of prior massive stroke
* Patients who had experienced a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris
* Severe chronic renal insufficiency or undergoing hemodialysis
* Patients treated with coumadin (warfarin) that had not been stopped within 72 before enrollment
* Medical conditions requiring oral anticoagulation
* Antiplatelet therapy with clopidogrel or dual antiplatelet as well as any other antithrombotic medication within 7 days prior to scheduled bypass surgery except unfractionated heparin or aspirin
* International normalized ratio (INR) \> 2.0
* Known hypersensitivity to heparin
* Patient not tolerating aspirin
* Previous history of bypass surgery in the target limb
* Patient with category 6 ischemia (tissue loss)
* Acute limb ischemia of any grade (0-3)
* Patient with no outflow beyond the popliteal artery
* Pregnant or may become pregnant during the course of the study
* Uncontrolled arterial hypertension (BP \> 200 mmHg) at 2 successive readings
* Anaemia (hemoglobin \< 8 g/ml)
* Thrombocytopenia \< 50 g/L
* Active bleeding according to clinical judgment
* Infected wet gangrene of any size and location at the target limb
* Compromised arterial flow
* Patient unwilling or unable to comply with follow-up requirements

Primary outcomes:
measure: Participants With Primary Graft Patency at 12 Months
timeFrame: 12 Months
Secondary outcomes:
measure: Participants With Secondary Graft Patency at 12 Months
timeFrame: 12 Months
measure: Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months
timeFrame: 30 days, 6 months, 12 months
measure: Rutherford Category at 30 Days, 6 Months and 12 Months
timeFrame: 30 days, 6 months, 12 months
measure: Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
timeFrame: 12 Months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Wilhelminenspital Vienna
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Karlsruhe
country: Germany
facility: Klinikum Karlsruhe
city: Kevelaer
country: Germany
facility: Marienhospital Kevelaer
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: München
country: Germany
facility: Klinikum München-Pasing
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Rheine
country: Germany
facility: Mathias-Spital
city: Stuttgart
country: Germany
facility: Katharinenhospital
Study officials:
affiliation: Klinikum rechts der Isar
name: Prof. Eckstein
role: PRINCIPAL_INVESTIGATOR
affiliation: Wilhelminenspital Vienna
name: Afshin Assadian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Assadian A, Eckstein HH; Peripheral Bypass Grafting: Prospective Evaluation of FUSION Vascular Graft for Above Knee Targets (PERFECTION) Study Group. Outcome of the FUSION vascular graft for above-knee femoropopliteal bypass. J Vasc Surg. 2015 Mar;61(3):713-9.e1. doi: 10.1016/j.jvs.2014.10.005. Epub 2014 Dec 10.