Dacron vs Dardik for Fem-Pop Bypass (DaDa)

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00523263
First received: August 30, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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

  Eligibility

Ages Eligible for Study:   31 Years to 89 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: August 30, 2007
Last Updated: August 30, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Intermittent Claudication
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Signs and Symptoms
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 18, 2014