Condition category
Circulatory System
Date applied
03/08/2005
Date assigned
05/10/2005
Last edited
20/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jes Lindholt

ORCID ID

Contact details

Vascular Research Unit
Viborg Hospital
Postbox 130
Viborg
8800
Denmark
+45 89272447
jes.s.lindholt@sygehusviborg.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Endoluminal heparinised polytetrafluoroethylene (PTFE) grafts reduces early occlusion.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Lower limb ischaemia

Intervention

Use of endoluminal heparinised PTFE graft instead of unheparinised PTFE grafts.

Please note that recruitment for this trial completed on 31/12/2008 and the trial is in follow-up as of 20/08/2009. Publication expected in Autumn 2010.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Patency

Secondary outcome measures

1. Secondary interventions
2. Cost effectiveness
3. Amputations

Overall trial start date

01/07/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with chronic lower limb ischeamia, who require a femoropopliteal or femorofemoral bypass with the use of an artificial graft

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

484

Participant exclusion criteria

Acute lower limb ischaemia, expected poor surveillance postoperatively, heparin allergy

Recruitment start date

01/07/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Denmark

Trial participating centre

Vascular Research Unit
Viborg
8800
Denmark

Sponsor information

Organisation

W. L. Gore and Associates (Sweden)

Sponsor details

Box 268
Mölndal
SE-431 23
Sweden
+46 45892650
lcederbye@wlgore.com

Sponsor type

Industry

Website

http://www.gore.com

Funders

Funder type

Industry

Funder name

Price difference of the two types of grafts is covered by W. L. Gore and Associates (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes