EKOS and r-tPA thrombolysis in Pulmonary Embolism (OPTALYSE STUDY)

• Research type

  Research Study

• Full title

  Study of the Optimum Duration of Acoustic Pulse Thrombolysis (APT) Procedure in the Treatment of Acute Submassive Pulmonary Embolism (OPTALYSE PE).

• IRAS ID

  201715

• Contact name

  Lynn Allen

• Contact email

  Lynn.Allen@ekoscorp.com

• Sponsor organisation

  EKOS Corporation

• Eudract number

  2016-000502-11

• Clinicaltrials.gov Identifier

  NCT02396758

• Duration of Study in the UK

  1 years, 7 months, 28 days

• Research summary

  Pulmonary embolism (PE) is a condition where a clot(s) lodges in a pulmonary artery. There are 3 classifications : (i) massive (ii) submassive and (iii) low risk. Submassive PE involves blood clots which interfere with blood flow through the heart and lungs, causing impairment of the right ventricle (right lower chamber of the heart).

  Acoustic Pulse Thrombolysis (APT) is the combination of ultrasound energy and a clot dissolving drug. In the current study, the medical device for delivering ultrasound energy is EKOS (EkoSonic Endovascular System). The clot dissolving drug is r-tPA. Delivery of drug and ultrasound is achieved by catheter insertion into the groin which is then guided using X-ray images to the clot location. The EKOS device and r-tPA are approved for use in PE by regulatory agencies in the US and UK.
  Catheter infusion delivers a drug effectively directly into the clot instead of an intravenous injection. Combining with Ultrasound helps the drug penetrate the clot quicker. In previous studies maximum drug dose was approximately 24mg and infusion times ranged from 18 to 24 hours. The current study is designed to investigate lower doses and shorter infusion times.
  Participants with submassive PE will be assigned randomly (allocated by chance) to receive one of 4 treatments:

  APT procedure duration r-tPA infusion rate total r-tPA dose
  (hours) (mg/hr/catheter) (mg)
  2 2 4 or 8
  4 1 4 or 8
  6 1 6 or 12
  6 2 12 or 24

  24 specialist cardiology clinics in America and one UK centre will participate, enrolling 150 subjects.

  On admission, baseline assessments are completed 48 hours before APT is started. Subjects will be closely monitored as inpatients for up to 3 days post treatment and then followed up in clinic after 1, 3, and 12 months and at 6 and 9 months by phone or email.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  16/SW/0120

• Date of REC Opinion

  21 Jul 2016

• REC opinion

  Further Information Favourable Opinion