Back to resultsMulticentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
Primary Purpose
Peripheral Vascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Bridging by PTFE with bounded heparin
Bridging by PTFE without bounded heparin
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Diseases
Eligibility 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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
PTFE with bounded heparin
PTFE without bounded heparin
Outcomes
Primary Outcome Measures
Primary patency after 2 years
Secondary Outcome Measures
Secondary patency
Limb salvage
Mortality
Re-intervention
Full Information
NCT ID
NCT00147979
First Posted
September 6, 2005
Last Updated
December 4, 2014
Sponsor
University Hospital, Ghent
Collaborators
JOTEC Company
1. Study Identification
Unique Protocol Identification Number
NCT00147979
Brief Title
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
Official Title
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
JOTEC Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
596 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
PTFE with bounded heparin
Arm Title
2
Arm Type
Active Comparator
Arm Description
PTFE without bounded heparin
Intervention Type
Device
Intervention Name(s)
Bridging by PTFE with bounded heparin
Intervention Description
Bridging by PTFE with bounded heparin
Intervention Type
Device
Intervention Name(s)
Bridging by PTFE without bounded heparin
Intervention Description
Bridging by PTFE without bounded heparin
Primary Outcome Measure Information:
Title
Primary patency after 2 years
Time Frame
after 2 years
Secondary Outcome Measure Information:
Title
Secondary patency
Time Frame
after 2 years
Title
Limb salvage
Time Frame
after 2 years
Title
Mortality
Time Frame
after 2 years
Title
Re-intervention
Time Frame
after 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Vermassen, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
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