Patency of luminal heparinised polytetrafluoroethylene (PTFE) grafts compared with unheparinised PTFE grafts
| ISRCTN | ISRCTN77471962 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77471962 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/08/2005
- Registration date
- 05/10/2005
- Last edited
- 20/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jes Lindholt
Scientific
Scientific
Vascular Research Unit
Viborg Hospital
Postbox 130
Viborg
8800
Denmark
| Phone | +45 89272447 |
|---|---|
| jes.s.lindholt@sygehusviborg.dk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Endoluminal heparinised polytetrafluoroethylene (PTFE) grafts reduces early occlusion. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Patency |
| Secondary outcome measures | 1. Secondary interventions 2. Cost effectiveness 3. Amputations |
| Overall study start date | 01/07/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 484 |
| Key inclusion criteria | Patients with chronic lower limb ischeamia, who require a femoropopliteal or femorofemoral bypass with the use of an artificial graft |
| Key exclusion criteria | Acute lower limb ischaemia, expected poor surveillance postoperatively, heparin allergy |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Vascular Research Unit
Viborg
8800
Denmark
8800
Denmark
Sponsor information
W. L. Gore and Associates (Sweden)
Industry
Industry
Box 268
Mölndal
SE-431 23
Sweden
| Phone | +46 45892650 |
|---|---|
| lcederbye@wlgore.com | |
| Website | http://www.gore.com |
"ROR" |
https://ror.org/0428qnk54 |
Funders
Funder type
Industry
Price difference of the two types of grafts is covered by W. L. Gore and Associates (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
