The PROMISE Study CLP 9508.B

• Research type

  Research Study

• Full title

  The PROMISE Study: A Prospective, Multicenter, Observation, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke

• IRAS ID

  210612

• Contact name

  Rocío Barraza

• Contact email

  rbarraza@penumbrainc.com

• Sponsor organisation

  Penumbra, Inc.

• Clinicaltrials.gov Identifier

  NCT02678169

• Duration of Study in the UK

  0 years, 8 months, 30 days

• Research summary

  The “PROMISE” Study consists of a prospective, single-arm, multicenter observational registry including patients presenting within 6 hours of symptom onset of an acute ischemic stroke due to anterior circulation large vessel occlusion. Follow-up visits will be performed at 24 hours, 7-10 days, discharge, 30 days, and 90 days after the procedure. The patient’s functional outcome and adverse events will be reviewed. In addition a quality of life questionnaire will be performed, in accordance with the site’s routine practice with all patients who have suffered an acute ischemic stroke. The duration of the study is 1 year.

• REC name

  London - Camden & Kings Cross Research Ethics Committee

• REC reference

  17/LO/0061

• Date of REC Opinion

  17 Mar 2017

• REC opinion

  Further Information Favourable Opinion