Dacron vs Dardik for Fem-Pop Bypass

Intermittent Claudication Clinical Trial

— DaDa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523263
• Other study ID #: DaDa-trial
• 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
• 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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Atheroslerosis
• Intermittent Claudication

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