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Dacron vs Dardik for Fem-Pop Bypass (DaDa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00523263
Recruitment Status : Completed
First Posted : August 31, 2007
Last Update Posted : August 31, 2007
Sponsor:
Information provided by:
Radboud University

Brief Summary:
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 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
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. 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
Criteria

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

Information from the National Library of Medicine

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


Locations
Netherlands
Radboud UMCN, Dept Vascular Surgery
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
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