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Evaluation of FUSION™ Vascular Graft for Above Knee Targets (PERFECTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01601496
Recruitment Status : Terminated (Slow Enrollment)
First Posted : May 18, 2012
Results First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Occlusive Disease (PAOD) Device: FUSION Vascular Graft Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients treated with the FUSION Vascular Graft
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)
Actual Study Start Date : October 26, 2009
Actual Primary Completion Date : July 24, 2013
Actual Study Completion Date : July 24, 2013

Arm Intervention/treatment
Experimental: FUSION Vascular Graft
All subjects who received a FUSION Vascular Graft at the baseline implant procedure.
Device: FUSION Vascular Graft
All subjects who received the FUSION Vascular Graft at the baseline implant procedure.




Primary Outcome Measures :
  1. Participants With Primary Graft Patency at 12 Months [ Time Frame: 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 :
  1. Participants With Secondary Graft Patency at 12 Months [ Time Frame: 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.

  2. Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months [ Time Frame: 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.

  3. Rutherford Category at 30 Days, 6 Months and 12 Months [ Time Frame: 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).

  4. Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601496


Locations
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Austria
Wilhelminenspital Vienna
Vienna, Austria, A-1160
Germany
Klinikum Darmstadt
Darmstadt, Germany, 64283
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany, 60590
Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Marienhospital Kevelaer
Kevelaer, Germany, 47623
Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
Klinikum München-Pasing
München, Germany, 81241
Klinikum rechts der Isar
München, Germany, 81675
Mathias-Spital
Rheine, Germany, 48431
Katharinenhospital
Stuttgart, Germany, 70147
Sponsors and Collaborators
Maquet Cardiovascular
Investigators
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Principal Investigator: Prof. Eckstein Klinikum rechts der Isar
Principal Investigator: Afshin Assadian, MD Wilhelminenspital Vienna
Publications of Results:
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Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01601496    
Other Study ID Numbers: VR7000856
First Posted: May 18, 2012    Key Record Dates
Results First Posted: October 14, 2020
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases