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Dacron vs Dardik for Fem-Pop Bypass (DaDa)

This study has been completed.
Information provided by:
Radboud University Identifier:
First received: August 30, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.

Condition Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Primary and primary-assisted bypass patency [ Time Frame: 1 - 5 yrs ]

Secondary Outcome Measures:
  • Secondary bypass patency [ Time Frame: 1 - 5 yrs ]

Study Start Date: January 1996
Study Completion Date: April 2007
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00523263

Radboud UMCN, Dept Vascular Surgery
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Principal Investigator: J. Adam van der Vliet, MD, PhD Radboud University Medical Center Nijmegen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00523263     History of Changes
Other Study ID Numbers: DaDa-trial
Study First Received: August 30, 2007
Last Updated: August 30, 2007

Additional relevant MeSH terms:
Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on June 22, 2017