No registrations found.
ID
Source
Brief title
Health condition
Patients with chronic renal failure who require a prosthetic vascular access for haemodialysis.
Sponsors and support
Mr PL Birch
Chief Executive Officer
21 Wilson Street
London EC2M 2TD, UK
Tel. +44 1428 683 351
philip.birch@veryanmed.com
Intervention
Outcome measures
Primary outcome
Patency rates.
Secondary outcome
1. Adverse events;
2. Clinical experiences.
Background summary
In this prospective feasibility study a new vascular access prosthesis, the SWIRLGRAFT, is tested in haemodialysis patients. Based on its helical geometry it is supposed to diminish stenosis at the venous anastomosis resulting in improved patency rates.
Study objective
The helical geometry of this vascular access prosthesis reduces flow stagnation and low shear stress at the venous anastomosis resulting in diminished neointimal hyperplasia.
Study design
N/A
Intervention
Implantation of a SWIRLGRAFT vascular access graft.
This single procedure (60-90 minutes) will be implemented in all participants and the prosthesis will remain in situ.
HP F 03.223,
P.O.Box 85500
H.J.T.A.M. Huijbregts
Heidelberglaan 100
Utrecht 3508 GA
The Netherlands
+31 (0)30 2507379
R.Huijbregts@azu.nl
HP F 03.223,
P.O.Box 85500
H.J.T.A.M. Huijbregts
Heidelberglaan 100
Utrecht 3508 GA
The Netherlands
+31 (0)30 2507379
R.Huijbregts@azu.nl
Inclusion criteria
1. Patients with chronic renal failure who require prosthetic vascular access for haemodialysis;
2. Informed consent and willing to co-operate;
3. Age 18 or older.
Exclusion criteria
1. Inability to comply with the study follow-up;
2. Known sensitivity to ePTFE;
3. Failure to obtain written informed consent;
4. Patients who have a history of chronic bacterial infection, during the 12 months prior to potential inclusion in the study;
5. Patients with known severe coagulation disorders;
6. Inability to attend all follow up visits;
7. Patients who are on coumarin therapy;
8. Patients who are at risk of steal syndrome due to poor condition of the peripheral arterial vessels, as identified by pre-operative Duplex scan;
9. Pregnancy, intension to become pregnant.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL393 |
| NTR-old | NTR432 |
| Other | : N/A |
| ISRCTN | ISRCTN11502523 |