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
  Purpose

The purpose of the study is to evaluate the safety and efficacy of the the FUSION™ Vascular Graft.


Condition Intervention
Peripheral Arterial Occlusive Disease
Device: FUSION™ Vascular Graft

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Study of PERipheral Bypass GraFting: ProspECTive Evaluation of FUSION™ Vascular Graft for Above Knee Targets(PERFECTION)

Further study details as provided by Maquet Cardiovascular:

Primary Outcome Measures:
  • Primary Efficacy Endpoint [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Primary Patency at 12 months


Secondary Outcome Measures:
  • 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


Enrollment: 117
Study Start Date: September 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Rechts der Isar Munich
Munchen, Germany, 81675
Klinikum Munich- Pasing
Munchen, Germany, 81241
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

No publications provided

Responsible Party: Maquet Cardiovascular
ClinicalTrials.gov Identifier: NCT01601496     History of Changes
Other Study ID Numbers: VR7000856
Study First Received: April 23, 2012
Last Updated: January 15, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on April 17, 2014