Dacron vs Dardik for Fem-Pop Bypass - Tabular View

Tracking Information

First Received Date ^ICMJE

August 30, 2007

Last Updated Date

August 30, 2007

Start Date ^ICMJE

January 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Dacron vs Dardik for Fem-Pop Bypass

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Intermittent Claudication
Arterial Occlusive Diseases
Atheroslerosis

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Active Comparator: Patients receiving polyester above-knee femoro-popliteal bypass
Active Comparator: patients receiving HUV femoro-popliteal bypass

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

31 Years to 89 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00523263

Responsible Party

Study ID Numbers ^ICMJE

DaDa-trial

Study Sponsor ^ICMJE

Radboud University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

J. Adam van der Vliet, MD, PhD

Radboud University Medical Center Nijmegen

Information Provided By

Radboud University

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP