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
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