Dacron vs Dardik for Fem-Pop Bypass (DaDa)
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ClinicalTrials.gov Identifier: NCT00523263 |
Recruitment Status
:
Completed
First Posted
: August 31, 2007
Last Update Posted
: August 31, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intermittent Claudication Arterial Occlusive Diseases Atheroslerosis | Device: heparin-bonded and collagen coated polyster Device: Human umbilical vein femoro-popliteal bypass | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Heparin Bonded and Collagen Coated Polyester or Human Umbilical Vein for Femoropopliteal Bypass: a Prospective Randomised Multicentre Trial. |
Study Start Date : | January 1996 |
Actual Study Completion Date : | April 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Dacron
Patients receiving polyester above-knee femoro-popliteal bypass
|
Device: heparin-bonded and collagen coated polyster
femoro-popliteal bypass
|
Active Comparator: HUV
patients receiving HUV femoro-popliteal bypass
|
Device: Human umbilical vein femoro-popliteal bypass |
- Primary and primary-assisted bypass patency [ Time Frame: 1 - 5 yrs ]
- Secondary bypass patency [ Time Frame: 1 - 5 yrs ]

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Ages Eligible for Study: | 31 Years to 89 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age 31 to 89
- intermittent claudication
- ABI below 0.8
Exclusion Criteria:
- non elective surgery
- life expectancy below 2 yrs
- contraindication for anticoagulant therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523263
Netherlands | |
Radboud UMCN, Dept Vascular Surgery | |
Nijmegen, Netherlands, 6500 HB |
Principal Investigator: | J. Adam van der Vliet, MD, PhD | Radboud University Medical Center Nijmegen |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00523263 History of Changes |
Other Study ID Numbers: |
DaDa-trial |
First Posted: | August 31, 2007 Key Record Dates |
Last Update Posted: | August 31, 2007 |
Last Verified: | August 2007 |
Additional relevant MeSH terms:
Intermittent Claudication Arterial Occlusive Diseases Arteriosclerosis Vascular Diseases Cardiovascular Diseases Signs and Symptoms |
Calcium heparin Heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |