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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00523263
Other study ID # DaDa-trial
Secondary ID
Status Completed
Phase Phase 3
First received August 30, 2007
Last updated August 30, 2007
Start date January 1996
Est. completion date April 2007

Study information

Verified date August 2007
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 31 Years to 89 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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


Locations

Country Name City State
Netherlands Radboud UMCN, Dept Vascular Surgery Nijmegen

Sponsors (1)

Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Scharn DM, Oyen WJ, Klemm PL, Verhofstad AA, van der Vliet JA. Thrombogenicity and related biological properties of heparin bonded collagen coated polyester and human umbilical vein prosthetic vascular grafts. J Surg Res. 2006 Aug;134(2):182-9. Epub 2006 Mar 20. — View Citation

Scharn DM, Oyen WJ, Klemm PL, Wijnen MH, vanderVliet JA. Assessment of prosthetic vascular graft thrombogenicity using the technetium-99m labeled glycoprotein IIb/IIIa receptor antagonist DMP444 in a dog model. Cardiovasc Surg. 2002 Dec;10(6):566-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary and primary-assisted bypass patency 1 - 5 yrs
Secondary Secondary bypass patency 1 - 5 yrs
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