Not Signed In -
Heparin Injection |
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Clinical Trial: Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE
This study is currently recruiting patients.
Verified by University Hospital Ghent September 2005
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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 or without bounded heparin |
MedlinePlus related topics: Peripheral Vascular Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: Primary patency after 2 years
Secondary Outcomes: Secundary patency; Limb salvage; Mortality; Re-intervention
Expected Total Enrollment: 596
Secondary Outcomes: Secundary patency; Limb salvage; Mortality; Re-intervention
Expected Total Enrollment: 596
Study start: April 2004
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 above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00147979
Frans Vermassen, MD, PhD 0032/(0)9/240.32.23 frans.vermassen@UGent.be
Belgium
University Hospital Ghent, Ghent, 9000, Belgium; Recruiting
B. Jacobs, MD 0032/(0)9/240.48.91 email: ???
Study chairs or principal investigators
Frans Vermassen, MD, PhD, Principal Investigator, University Hospital Ghent
More Information
Website University Hospital Ghent
Study ID Numbers: 2004/042
Last Updated: September 6, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00147979
Health Authority: Belgium: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 6, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00147979
Health Authority: Belgium: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Heparin Injection (Drug Digest)
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