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
  Purpose

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


Condition Intervention
Peripheral Vascular Diseases
Device: Bridging by PTFE with bounded heparin
Device: Bridging by PTFE without bounded heparin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Primary patency after 2 years [ Time Frame: after 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 596
Study Start Date: April 2004
Estimated Study Completion Date: August 2013
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PTFE with bounded heparin
Device: Bridging by PTFE with bounded heparin
Bridging by PTFE with bounded heparin
Active Comparator: 2
PTFE without bounded heparin
Device: Bridging by PTFE without bounded heparin
Bridging by PTFE without bounded heparin

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147979

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
JOTEC Company
Investigators
Principal Investigator: Frank Vermassen, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00147979     History of Changes
Other Study ID Numbers: 2004/042
Study First Received: September 6, 2005
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014