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OpenTrials
Completed

NCT Number: NCT00523263

Dacron vs Dardik for Fem-Pop Bypass

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.

Completed

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Key information

Conditions

Intermittent Claudication Arterial Occlusive Diseases Atheroslerosis Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

31 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Radboud UMCN, Dept Vascular Surgery

Nijmegen, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heparin-bonded and collagen coated polyster

Device

femoro-popliteal bypass

Human umbilical vein femoro-popliteal bypass

Device

Primary outcomes

  1. Primary and primary-assisted bypass patency

    Time frame: 1 - 5 yrs

Secondary outcomes

  1. Secondary bypass patency

    Time frame: 1 - 5 yrs

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Heparin Bonded and Collagen Coated Polyester or Human Umbilical Vein for Femoropopliteal Bypass: a Prospective Randomised Multicentre Trial.

Acronym: DaDa

Important dates

Study start
1996
Study completion
2007
First posted
Aug 31, 2007
Registry last updated
Aug 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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