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A multicentre clinical study of the SWIRLGRAFT ePTFE vascular access graft.


- candidate number1423
- NTR NumberNTR432
- ISRCTNISRCTN11502523
- Date ISRCTN created27-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleA multicentre clinical study of the SWIRLGRAFT ePTFE vascular access graft.
- Scientific TitleA multicentre clinical study of the SWIRLGRAFT ePTFE vascular access graft.
- ACRONYMN/A
- hypothesisThe helical geometry of this vascular access prosthesis reduces flow stagnation and low shear stress at the venous anastomosis resulting in diminished neointimal hyperplasia.
- Healt Condition(s) or Problem(s) studiedRenal insufficiency
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2004
- planned closingdate31-dec-2006
- Target number of participants25
- InterventionsImplantation 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.
- Primary outcomePatency rates.
- Secondary outcome1. Adverse events;
2. Clinical experiences.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. H.J.T.A.M. Huijbregts
- CONTACT for SCIENTIFIC QUERIESMD. PhD. F.L. Moll
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Veryan Medical Ltd
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD6-sep-2005 - 14-sep-2009


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