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

ISRCTN	ISRCTN11502523
DOI	https://doi.org/10.1186/ISRCTN11502523
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	NL393 (NTR432)
Sponsor	University Medical Centre Utrecht (UMCU) (The Netherlands)
Funder	Veryan Medical Ltd (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr H J T A M Huijbregts
Scientific

University Medical Centre Utrecht (UMCU)
HP F 03.223
P.O. Box 85500
Heidelberglaan 100
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 250 7379
Email	R.Huijbregts@azu.nl

Primary study design	Interventional
Study design	Prospective, parallel group, multicentre feasibility study
Secondary study design	Multi-centre
Scientific title	A multicentre clinical study of the SWIRLGRAFT expanded polytetrafluoroethylene vascular access graft
Study objectives	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. Hypothesis: The helical geometry of this vascular access prosthesis reduces flow stagnation and low shear stress at the venous anastomosis resulting in diminished neointimal hyperplasia.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Chronic renal insufficiency
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.
Intervention type	Other
Primary outcome measure(s)	Patency rates
Key secondary outcome measure(s)	1. Adverse events 2. Clinical experiences
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	25
Total final enrolment	20
Key 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
Key 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
Date of first enrolment	01/12/2004
Date of final enrolment	31/12/2006

University Medical Centre Utrecht (UMCU)

Utrecht
3508 GA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/04/2007	26/03/2021	Yes	No

26/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.