WL Gore VSX

• Research type

  Research Study

• Full title

  Observational GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Global Registry

• IRAS ID

  299806

• Contact name

  Peter Mezes

• Contact email

  Peter.Mezes@nbt.nhs.uk

• Sponsor organisation

  W.L Gore & Associates, Inc.

• Clinicaltrials.gov Identifier

  NCT04907240

• Duration of Study in the UK

  14 years, 0 months, 0 days

• Research summary

  This is a multi-centre, single- arm, post- market registry, where a minimum of 614 patients will be recruited across 35 sites. The primary aim of the study is to collect data from patients who have been treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)for a variety of medical reasons as stated below, to assess the safety of the device.
  - Lesion in the Iliac arteries: Damage in the iliac arteries (the vessels that supply blood to the pelvis, pelvic organs, reproductive organs, and the medial part of the thigh and lower body.
  - Lesion in the superficial femoral artery and proximal popliteal artery (SFA): SFA: Damage to the large main thigh artery and the artery running behind the knee which supply blood to the muscles in the lower leg and heel.
  - In-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery (SFA ISR): Narrowing or re-narrowing of the large main thigh artery and the artery running behind the knee which supply blood to the muscles in the lower leg and heel.
  - Hemodialysis (AV) Access: Access for the hemodialysis (“blood washing”) where a machine filters wastes, salts and fluid from your blood when your kidneys are no longer able to do so.
  - Popliteal artery aneurysms (PAA): Widening of the artery running behind the knee.
  - Isolated visceral artery aneurysms (VAA): Widening of the artery in your abdomen that supply blood to the intestines, spleen and liver.
  - Trauma / Injury: use in an accident or injury of a blood vessel
  - Other: any other use not captured above

  Each patient will have data collected from their procedure and standard of care follow up visits. Patients may be asked to complete a quality of life questionnaire for up to two years into their follow up.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  21/LO/0831

• Date of REC Opinion

  22 Dec 2021

• REC opinion

  Further Information Favourable Opinion