NCT00300690

Brief Summary

This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 1993

Longer than P75 for phase_4

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

October 1, 1993

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1999

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
Last Updated

March 9, 2006

Status Verified

March 1, 2006

First QC Date

March 8, 2006

Last Update Submit

March 8, 2006

Conditions

Intermittent ClaudicationCritical Limb Ischemia

Keywords

Lower extremity bypass surgeryfemoro-popliteal bypassDacron materialPTFE material

Outcome Measures

Primary Outcomes (1)

  • Primary uncorrected graft patency after 2 years

Secondary Outcomes (3)

  • - Secondary graft patency after two years

  • - Limb survival after two years

  • - Complication rate perioperatively

Interventions

6 mm Uni-graft® (B-Braun)DEVICE
6 mm Gore-Tex® (WL Gore)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery.

You may not qualify if:

  • pregnancy
  • No consent to participate in the study
  • Previous enrollment in the study
  • follow-up is not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intermittent ClaudicationChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive DiseasesChronic DiseaseDisease AttributesPathologic ProcessesIschemia

Study Officials

  • Torben V Schroeder, Professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2006

First Posted

March 9, 2006

Study Start

October 1, 1993

Study Completion

January 1, 1999

Last Updated

March 9, 2006

Record last verified: 2006-03