Evaluation of FUSION™ Vascular Graft for Above Knee Targets

Not Applicable

Terminated

Conditions: Peripheral Arterial Occlusive Disease (PAOD)

Interventions: Device: FUSION Vascular Graft

Registration Number: NCT01601496

Lead Sponsor: Maquet Cardiovascular

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 117

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FUSION Vascular Graft	FUSION Vascular Graft	All subjects who received a FUSION Vascular Graft at the baseline implant procedure.

Primary Outcome Measures

Name	Time	Method
Participants With Primary Graft Patency at 12 Months	12 Months	Subjects were assessed to have had primary graft patency at 12 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 interventions. Patency was assessed by duplex ultrasound imaging.

Secondary Outcome Measures

Name	Time	Method
Participants With Secondary Graft Patency at 12 Months	12 Months	Subjects were assessed to have had secondary graft patency at 12 months. Secondary graft patency was defined as a graft patency established by another intervention to remediate occlusion within 12 months after surgery.
Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months	30 days, 6 months, 12 months	Ankle-brachial index at 30 days, 6 months, and 12 months. The ankle-brachial index is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.
Rutherford Category at 30 Days, 6 Months and 12 Months	30 days, 6 months, 12 months	Rutherford category at 30 days, 6 months and 12 months. Rutherford classification is a staging system to describe lower extremity ischemia, and is assigned by the Investigator. Higher grades represent more severe disease, ranging from asymptomatic (category 0) to major tissue loss (category 6).
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death	12 Months	Major Adverse Limb Events (MALE) were defined as major amputation (any amputation that resulted in limb shortening) or major graft reintervention (including placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision (explant), or graft thrombolysis). Periprocedural Death (POD) was defined as death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomical site or as a result of the initial procedure.

Trial Locations

Locations (10): Universitätsklinikum Frankfurt
🇩🇪
Frankfurt am Main, Germany
Klinikum Darmstadt
🇩🇪
Darmstadt, Germany
Klinikum Ludwigsburg
🇩🇪
Ludwigsburg, Germany
Katharinenhospital
🇩🇪
Stuttgart, Germany
Klinikum München-Pasing
🇩🇪
München, Germany
Wilhelminenspital Vienna
🇦🇹
Vienna, Austria
Marienhospital Kevelaer
🇩🇪
Kevelaer, Germany
Klinikum Karlsruhe
🇩🇪
Karlsruhe, Germany
Klinikum rechts der Isar
🇩🇪
München, Germany
Mathias-Spital
🇩🇪
Rheine, Germany