Dacron vs Dardik for Fem-Pop Bypass

NCT ID: NCT00523263

Last Updated: 2007-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1996-01-31

Study Completion Date

2007-04-30

Brief Summary

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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

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Conditions

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Intermittent Claudication Arterial Occlusive Diseases Atheroslerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dacron

Patients receiving polyester above-knee femoro-popliteal bypass

Group Type ACTIVE_COMPARATOR

heparin-bonded and collagen coated polyster

Intervention Type DEVICE

femoro-popliteal bypass

HUV

patients receiving HUV femoro-popliteal bypass

Group Type ACTIVE_COMPARATOR

Human umbilical vein femoro-popliteal bypass

Intervention Type DEVICE

Interventions

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heparin-bonded and collagen coated polyster

femoro-popliteal bypass

Intervention Type DEVICE

Human umbilical vein femoro-popliteal bypass

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

31 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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J. Adam van der Vliet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center Nijmegen

Locations

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Radboud UMCN, Dept Vascular Surgery

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 16542682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12453688 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18675557 (View on PubMed)

Other Identifiers

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DaDa-trial

Identifier Type: -

Identifier Source: org_study_id