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Dacron vs Dardik for Fem-Pop Bypass (DaDa)

Primary Purpose

Intermittent Claudication, Arterial Occlusive Diseases, Atheroslerosis

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
heparin-bonded and collagen coated polyster
Human umbilical vein femoro-popliteal bypass
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication

Eligibility Criteria

31 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud UMCN, Dept Vascular Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dacron

HUV

Arm Description

Patients receiving polyester above-knee femoro-popliteal bypass

patients receiving HUV femoro-popliteal bypass

Outcomes

Primary Outcome Measures

Primary and primary-assisted bypass patency

Secondary Outcome Measures

Secondary bypass patency

Full Information

First Posted
August 30, 2007
Last Updated
August 30, 2007
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00523263
Brief Title
Dacron vs Dardik for Fem-Pop Bypass
Acronym
DaDa
Official Title
Heparin Bonded and Collagen Coated Polyester or Human Umbilical Vein for Femoropopliteal Bypass: a Prospective Randomised Multicentre Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
January 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Arterial Occlusive Diseases, Atheroslerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Dacron
Arm Type
Active Comparator
Arm Description
Patients receiving polyester above-knee femoro-popliteal bypass
Arm Title
HUV
Arm Type
Active Comparator
Arm Description
patients receiving HUV femoro-popliteal bypass
Intervention Type
Device
Intervention Name(s)
heparin-bonded and collagen coated polyster
Intervention Description
femoro-popliteal bypass
Intervention Type
Device
Intervention Name(s)
Human umbilical vein femoro-popliteal bypass
Primary Outcome Measure Information:
Title
Primary and primary-assisted bypass patency
Time Frame
1 - 5 yrs
Secondary Outcome Measure Information:
Title
Secondary bypass patency
Time Frame
1 - 5 yrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Adam van der Vliet, MD, PhD
Organizational Affiliation
Radboud University Medical Center Nijmegen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud UMCN, Dept Vascular Surgery
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
16542682
Citation
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. doi: 10.1016/j.jss.2006.01.025. Epub 2006 Mar 20.
Results Reference
background
PubMed Identifier
12453688
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. doi: 10.1016/s0967-2109(02)00077-7.
Results Reference
background
PubMed Identifier
18675557
Citation
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. doi: 10.1016/j.ejvs.2008.06.012.
Results Reference
derived

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Dacron vs Dardik for Fem-Pop Bypass

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