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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maquet Cardiovascular
ClinicalTrials.gov Identifier:
NCT01601496
First received: April 23, 2012
Last updated: January 15, 2014
Last verified: January 2014

April 23, 2012
January 15, 2014
September 2009
July 2013   (final data collection date for primary outcome measure)
Primary Efficacy Endpoint [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    Secondary Patency
  • Safety [ Time Frame: 30 Days, 6 Months, 12 Months ] [ Designated as safety issue: Yes ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT01601496
VR7000856
No
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