Condition category
Urological and Genital Diseases
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
27/02/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H J T A M Huijbregts

ORCID ID

Contact details

University Medical Centre Utrecht (UMCU)
HP F 03.223
P.O. Box 85500
Heidelberglaan 100
Utrecht
3508 GA
Netherlands
+31 (0)30 250 7379
R.Huijbregts@azu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Prospective, parallel group, multicentre feasibility study

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Patency rates

Secondary outcome measures

1. Adverse events
2. Clinical experiences

Overall trial start date

01/12/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

25

Participant 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

Recruitment start date

01/12/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcutrecht.nl/zorg/

Funders

Funder type

Industry

Funder name

Veryan Medical Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes