The helical geometry of this vascular access prosthesis reduces flow stagnation and low shear stress at the venous anastomosis resulting in diminished neointimal hyperplasia.
ID
Bron
Verkorte titel
Aandoening
Patients with chronic renal failure who require a prosthetic vascular access for haemodialysis.
Ondersteuning
Mr PL Birch
Chief Executive Officer
21 Wilson Street
London EC2M 2TD, UK
Tel. +44 1428 683 351
philip.birch@veryanmed.com
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Patency rates.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The helical geometry of this vascular access prosthesis reduces flow stagnation and low shear stress at the venous anastomosis resulting in diminished neointimal hyperplasia.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL393 |
| NTR-old | NTR432 |
| Ander register | : N/A |
| ISRCTN | ISRCTN11502523 |