everlinQ endoAVF Post-Market Study v2.0

• Research type

  Research Study

• Full title

  everlinQ endoAVF Post-Market Study

• IRAS ID

  201070

• Contact name

  Nicolas Inston

• Contact email

  Nicholas.inston2@uhb.nhs.uk

• Sponsor organisation

  TVA Medical, Inc.

• Clinicaltrials.gov Identifier

  NCT02682420

• Clinicaltrials.gov Identifier

  NCT02682420, ClinicalTrials.gov

• Duration of Study in the UK

  2 years, 1 months, 1 days

• Research summary

  The everlinQ endoAVF EU study is a multi-center post-market registry conducted in Europe to evaluate the everlinQ endoAVF System when used to create an endovascular (non-surgical) arteriovenous fistula (endoAVF) for patients who require vascular access for hemodialysis.
  The everlinQ endoAVF System, manufactured by TVA Medical, has received CE mark. This clinical study is being conducted to gather additional information on endovascular fistula creation using the everlinQ endoAVF System.
  The objective of the study is to collect data in an observational manner to further evaluate the outcomes of endovascular fistula creation using the everlinQ endoAVF System.
  Patients who receive an endoAVF will be required to return for follow-up visits at approximately 1, 3, 6, and 12 months after the procedure. Study participation will end after 12 months of follow-up.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  16/LO/0878

• Date of REC Opinion

  7 Jun 2016

• REC opinion

  Further Information Favourable Opinion