Dacron vs Dardik for Fem-Pop Bypass (DaDa)

Radboud University Medical Center

Status and phase: Completed; Phase 3

Conditions: Intermittent Claudication; Atheroslerosis; Arterial Occlusive Diseases

Treatments: Device: Human umbilical vein femoro-popliteal bypass; Device: heparin-bonded and collagen coated polyster

Study type: Interventional

Funder types: Other

Identifiers

NCT00523263

DaDa-trial

Details and patient eligibility

About

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.

Sex: All

Ages: 31 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Dacron

Active Comparator group

Description:

Patients receiving polyester above-knee femoro-popliteal bypass

Treatment:

Device: heparin-bonded and collagen coated polyster

HUV

Active Comparator group

Description:

patients receiving HUV femoro-popliteal bypass

Treatment:

Device: Human umbilical vein femoro-popliteal bypass