NCT00523263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1996

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1996

Completed
11.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
Last Updated

August 31, 2007

Status Verified

August 1, 2007

First QC Date

August 30, 2007

Last Update Submit

August 30, 2007

Conditions

Intermittent ClaudicationArterial Occlusive DiseasesAtheroslerosis

Outcome Measures

Primary Outcomes (1)

  • Primary and primary-assisted bypass patency

    1 - 5 yrs

Secondary Outcomes (1)

  • Secondary bypass patency

    1 - 5 yrs

Study Arms (2)

Dacron

ACTIVE COMPARATOR

Patients receiving polyester above-knee femoro-popliteal bypass

Device: heparin-bonded and collagen coated polyster

HUV

ACTIVE COMPARATOR

patients receiving HUV femoro-popliteal bypass

Device: Human umbilical vein femoro-popliteal bypass

Interventions

heparin-bonded and collagen coated polysterDEVICE

femoro-popliteal bypass

Dacron
Human umbilical vein femoro-popliteal bypassDEVICE
HUV

Eligibility Criteria

Age31 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 31 to 89
  • intermittent claudication
  • ABI below 0.8

You may not qualify if:

  • non elective surgery
  • life expectancy below 2 yrs
  • contraindication for anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud UMCN, Dept Vascular Surgery

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 16542682BACKGROUND

  • 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.

    PMID: 12453688BACKGROUND

  • 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.

    PMID: 18675557DERIVED

MeSH Terms

Conditions

Intermittent ClaudicationArterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • J. Adam van der Vliet, MD, PhD

    Radboud University Medical Center Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2007

First Posted

August 31, 2007

Study Start

January 1, 1996

Study Completion

April 1, 2007

Last Updated

August 31, 2007

Record last verified: 2007-08

Locations

NL(1)