Dacron vs Dardik for Fem-Pop Bypass - Full Text View

Purpose

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.

Condition	Intervention	Phase
Intermittent Claudication Arterial Occlusive Diseases Atheroslerosis	Device: heparin-bonded and collagen coated polyster Device: Human umbilical vein femoro-popliteal bypass	Phase III

ChemIDplus related topics:

Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Radboud University:

Primary Outcome Measures:

Primary and primary-assisted bypass patency [ Time Frame: 1 - 5 yrs ]

Secondary Outcome Measures:

Secondary bypass patency [ Time Frame: 1 - 5 yrs ]

Study Start Date:	January 1996
Study Completion Date:	April 2007

Arms	Assigned Interventions
Dacron: Active Comparator Patients receiving polyester above-knee femoro-popliteal bypass	Device: heparin-bonded and collagen coated polyster femoro-popliteal bypass
HUV: Active Comparator patients receiving HUV femoro-popliteal bypass	Device: Human umbilical vein femoro-popliteal bypass

Eligibility

Ages Eligible for Study:	31 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523263

Locations


Netherlands
	Radboud UMCN, Dept Vascular Surgery
	Nijmegen, Netherlands, 6500 HB

Sponsors and Collaborators

Radboud University

Investigators


Principal Investigator:	J. Adam van der Vliet, MD, PhD	Radboud University Medical Center Nijmegen

More Information

Publications:

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.

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.

Publications indexed to this study:

Dirven M, Scharn DM, Blankensteijn JD, van der Vliet JA. Preservation for future use of the autologous saphenous vein during femoro-popliteal bypass surgery is inexpedient. Eur J Vasc Endovasc Surg. 2008 Oct;36(4):420-3.

Study ID Numbers:	DaDa-trial
First Received:	August 30, 2007
Last Updated:	August 30, 2007
ClinicalTrials.gov Identifier:	NCT00523263
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Study placed in the following topic categories:

Arterial Occlusive Diseases

Signs and Symptoms

Vascular Diseases

Intermittent Claudication

Arteriosclerosis

Heparin

Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents

Anticoagulants

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Hematologic Agents

Fibrinolytic Agents

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00523263