Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
JOTEC Company
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00147979
First received: September 6, 2005
Last updated: February 1, 2013
Last verified: February 2013

September 6, 2005
February 1, 2013
April 2004
January 2009   (final data collection date for primary outcome measure)
Primary patency after 2 years [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
Primary patency after 2 years
Complete list of historical versions of study NCT00147979 on ClinicalTrials.gov Archive Site
  • Secondary patency [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
  • Limb salvage [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
  • Re-intervention [ Time Frame: after 2 years ] [ Designated as safety issue: No ]
  • Secundary patency
  • Limb salvage
  • Mortality
  • Re-intervention
Not Provided
Not Provided
 
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE

Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin

Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin.

Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Peripheral Vascular Diseases
  • Device: Bridging by PTFE with bounded heparin
    Bridging by PTFE with bounded heparin
  • Device: Bridging by PTFE without bounded heparin
    Bridging by PTFE without bounded heparin
  • Experimental: 1
    PTFE with bounded heparin
    Intervention: Device: Bridging by PTFE with bounded heparin
  • Active Comparator: 2
    PTFE without bounded heparin
    Intervention: Device: Bridging by PTFE without bounded heparin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
596
August 2013
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Peripheral Vascular Diseases with complaints of invalidating claudication, rest pain, ucera or gangrene
  • Patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm
  • Reasonable outflow arteria
  • Informed consent
  • Patient able to take part in all follow-up examinations

Exclusion Criteria:

  • Acute ischemia of the leg
  • Patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery
  • < 18 years
  • Pregnancy
  • Recent heart attack (< 1 month)
  • Life expectancy less than 12 months
  • Known allergy to heparin
  • Known contrast allergy
  • Known bleeding or coagulation disorder
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00147979
2004/042
No
University Hospital, Ghent
University Hospital, Ghent
JOTEC Company
Principal Investigator: Frank Vermassen, MD, PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

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