PiCSO-AMI-V Inferior STEMI

• Research type

  Research Study

• Full title

  A randomized controlled pilot study to evaluate safety and feasibility of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy in patients with extensive ST elevation inferior wall myocardial infarction presenting with TIMI 0 or 1 and symptom duration ≤ 12 hours treated adjunct to percutaneous coronary intervention (PCI) compared to standard PCI.

• IRAS ID

  302651

• Contact name

  Jozef Tanczos

• Contact email

  clinical@miracormedical.com

• Sponsor organisation

  Miracor Medical SA

• Clinicaltrials.gov Identifier

  NCT04958421

• Duration of Study in the UK

  2 years, 2 months, 31 days

• Research summary

  This feasibility study of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) therapy is aiming to asses whether the already CE marked PiCSO Impulse System for use in Anterior STEMI patients (patient suffering from heart attack that is caused by a blockage in the LAD - one of the three coronary arteries) would bring benefits also to patients suffering from Inferior STEMI (heart attack caused by a blockage in RCA - another artery of the three coronary arteries). Patients will be followed up for one year for safety outcomes within the study, their heart functions as well as the damage caused by the heart attack will be assessed.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  21/SC/0289

• Date of REC Opinion

  15 Nov 2021

• REC opinion

  Further Information Favourable Opinion