ROX CONTROL HTN REGISTRY: Protocol RH-03 Version 1.0, June 19, 2013

• Research type

  Research Study

• Full title

  ROX CONTROL HTN Registry: To Evaluate the ROX Coupler in Patients with Resistant or Uncontrolled Hypertension

• IRAS ID

  135320

• Contact name

  M Lobo

• Contact email

  m.d.lobo@qmul.ac.uk

• Clinicaltrials.gov Identifier

  NCT01885390

• Research summary

  The ROX Coupler is a self-expanding nitinol coupler that is delivered percutaneously to create an anastamosis between the iliac artery and vein. Safety and performance of the ROX Coupler will be evaluated in up to 100 subjects at up to 5 study sites. Patients with documented resistant or uncontrolled hypertension, who are interested in participating in the study, will provide informed consent prior to baseline to determine eligibility.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/1284

• Date of REC Opinion

  19 Nov 2013

• REC opinion

  Further Information Favourable Opinion