Arterial Occlusive Diseases, Atheroslerosis, Intermittent Claudication
Conditions
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.
Interventions
DEVICEheparin-bonded and collagen coated polyster
femoro-popliteal bypass
DEVICEHuman umbilical vein femoro-popliteal bypass
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
31 Years to 89 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary and primary-assisted bypass patency | 1 - 5 yrs |
Secondary
| Measure | Time frame |
|---|---|
| Secondary bypass patency | 1 - 5 yrs |
Countries
Netherlands
Outcome results
None listed