A multicentre clinical study of the SWIRLGRAFT expanded polytetrafluoroethylene vascular access graft

Not Applicable

Completed

• Conditions: Chronic renal insufficiency; Urological and Genital Diseases; Renal insufficiency

• Registration Number: ISRCTN11502523
• Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (The Netherlands)

Brief Summary

2007 results in https://doi.org/10.1016/j.ejvs.2006.10.028 (added 26/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-12-31
• Study Start: 2007-02-27
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

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 expanded Polytetrafluoroethylene (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, intention to become pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified