Hi-PEITHO; Study Reference Number: S2479
Research type
Research Study
Full title
A randomized trial of ultrasound-facilitated, catheter-directed, thrombolysis versus anticoagulation for acute intermediate-high risk pulmonary embolism: The higher-risk pulmonary embolism thrombolysis study
IRAS ID
300758
Contact name
Andrew Sharp
Contact email
Sponsor organisation
Boston Scientific Corporation
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Current approved treatment options for pulmonary embolism include blood thinner medications (anticoagulation) and treatment with EkoSonicTM Endovascular device to dissolve blood clots.
The purpose of this study is to determine whether treatment with standard of care anticoagulation medications in combination with the approved and commercially-available EkoSonicTM Endovascular device, which will deliver ultrasound energy to the area in and around the blood clot while a dose of a commercially available clot-dissolving drug (thrombolytic) will be introduced via a catheter (thin hollow tube) that will be inserted through the groin or neck and delivered to the blood clot in the lung, can reduce the risk of death and other serious problems when compared to standard of care anticoagulation medication alone. Study patients will be randomised into one of the treatment groups.
In addition to standard of care treatment, certain medical tests and assessments will be performed such as questionnaires regarding quality of life, 6 minute walk tests and echocardiograms following treatment. Study patients will be asked to return to the hospital for 3 additional follow up visits within 12 months following treatment, at 30 days, 6 months, and 12 months. The participation of study patients will be completed after the 12 month follow up visit.
REC name
Wales REC 6
REC reference
21/WA/0249
Date of REC Opinion
29 Sep 2021
REC opinion
Further Information Favourable Opinion