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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01601496
First Posted: May 18, 2012
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Maquet Cardiovascular
April 23, 2012
May 18, 2012
October 12, 2017
September 2009
July 2013   (Final data collection date for primary outcome measure)
Primary Efficacy Endpoint [ Time Frame: 12 Months ]
Primary Patency at 12 months
Same as current
Complete list of historical versions of study NCT01601496 on ClinicalTrials.gov Archive Site
  • Secondary Efficacy Endpoint [ Time Frame: 30 Day, 6 Months, 12 Months ]
    Secondary Patency
  • Safety [ Time Frame: 30 Days, 6 Months, 12 Months ]
    Post Operative Complications
Same as current
Not Provided
Not Provided
 
Evaluation of FUSION™ Vascular Graft for Above Knee Targets
Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)
The purpose of the study is to evaluate the safety and efficacy of the the FUSION™ Vascular Graft.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Peripheral Arterial Occlusive Disease
Device: FUSION™ Vascular Graft
All subjects receive FUSION™ Vascular Graft at baseline implant procedure
Experimental: FUSION™ Vascular Graft
All subjects receive FUSION™ Vascular Graft at baseline implant procedure
Intervention: Device: FUSION™ Vascular Graft
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
 
NCT01601496
VR7000856
No
Not Provided
Not Provided
Maquet Cardiovascular
Maquet Cardiovascular
Not Provided
Principal Investigator: Prof. Eckstein Klinikum rechts der Isar Munich
Principal Investigator: PD Dr. Afshin Assadian Wilhelminenspital Vienna
Maquet Cardiovascular
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP