Evaluation of FUSION™ Vascular Graft for Above Knee Targets

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-26

Study Completion Date

2013-07-24

Brief Summary

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

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Detailed Description

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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.

Conditions

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Peripheral Arterial Occlusive Disease (PAOD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients treated with the FUSION Vascular Graft

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FUSION Vascular Graft

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

Group Type EXPERIMENTAL

FUSION Vascular Graft

Intervention Type DEVICE

All subjects who received the FUSION Vascular Graft at the baseline implant procedure.

Interventions

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FUSION Vascular Graft

All subjects who received the FUSION Vascular Graft at the baseline implant procedure.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No