Patients with chronic renal failure who require a prosthetic vascular access for haemodialysis.
Conditions
Interventions
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.
Sponsors
Veryan Medical Ltd
Mr PL Birch
Chief Executive Officer
21 Wilson Street
London EC2M 2TD, UK
Tel. +44 1428 683 351
philip.birch@veryanmed.com
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency rates. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events; 2. Clinical experiences. | — |
Contacts
Public ContactH.J.T.A.M. Huijbregts
University Medical Center Utrecht (UMCU), HP F 03.223, P.O.Box 85500
Outcome results
None listed