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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 : Completed
First Posted : May 18, 2012
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to evaluate the safety and efficacy of the the FUSION™ Vascular Graft.

Condition or disease Intervention/treatment
Peripheral Arterial Occlusive Disease Device: FUSION™ Vascular Graft

Detailed Description:
This study is a prospective, single arm, multi-center study to evaluate the FUSION™ Vascular Graft patency at 30 days, 6 months, 1 year and post operative complications not associated with bypass patency.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)
Study Start Date : September 2009
Primary Completion Date : July 2013
Study Completion Date : July 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: FUSION™ Vascular Graft
All subjects receive FUSION™ Vascular Graft at baseline implant procedure
Device: FUSION™ Vascular Graft
All subjects receive FUSION™ Vascular Graft at baseline implant procedure


Outcome Measures

Primary Outcome Measures :
  1. Primary Efficacy Endpoint [ Time Frame: 12 Months ]
    Primary Patency at 12 months


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoint [ Time Frame: 30 Day, 6 Months, 12 Months ]
    Secondary Patency

  2. Safety [ Time Frame: 30 Days, 6 Months, 12 Months ]
    Post Operative Complications


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Peripheral arterial occlusive disease requiring treatment of the femoral artery
  • Patient is not participating in other clinical trials that would conflict with this protocol
  • Patient willing and able to have follow-up visits and exams

Exclusion Criteria:

  • Life expectancy of less than one year
  • Patients treated with coumadin (warfarin) prior to baseline procedure
  • Antiplatelet therapy within 7 days of baseline procedure
Contacts and Locations

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
Austria
Wilhelminenspital Vienna
Vienna, Austria, A-1160
Germany
Klinikum Augsburg
Augsburg, Germany, 86156
Klinikum Darmstadt
Darmstadt, Germany, 64283
Uniklinik Frankfurt
Frankfurt am Main, Germany, 60590
Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Marienhospital Kevelaer
Kevelaer, Germany, 47623
Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
Klinikum Munich- Pasing
Munchen, Germany, 81241
Klinikum Rechts der Isar Munich
Munchen, Germany, 81675
Mathias-Spital Rheine
Rheine, Germany, 48431
Katharinehospital Stuttgart
Stuttgart, Germany, 70147
Uniklinik Wurzburg
Wurzburg, Germany, 97080
Sponsors and Collaborators
Maquet Cardiovascular
Investigators
Principal Investigator: Prof. Eckstein Klinikum rechts der Isar Munich
Principal Investigator: PD Dr. Afshin Assadian Wilhelminenspital Vienna
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01601496     History of Changes
Other Study ID Numbers: VR7000856
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases