KNOCOUT PE
Research type
Research Study
Full title
Retrospective and prospective international EKoSoNic® registry Of the treatment and Clinical OUTcomes of patients with Pulmonary Embolism
IRAS ID
242800
Contact name
Andrew Sharp
Contact email
Sponsor organisation
EKOS Corporation
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EudraCT, 2018-001235-46
Duration of Study in the UK
2 years, 9 months, 30 days
Research summary
Research Summary
The KNOCOUT Study is an international registry that aims to collect treatment and clinical outcome data from patients with pulmonary embolism (clot in the lungs) and who are treated with the Acoustic Pulse Thrombolysis (APT) Procedure. The APT Procedure involves the use of the EkoSonic® Endovascular System (EKOS) device in combination with recombinant tissue plasminogen activator (r-tPA) administration (clot dissolving drug), both of which are commercially available.
The purpose of this registry is to understand how doctors are currently treating pulmonary embolism with clot dissolving drugs and EKOS. Data collected for the registry will focus on length of treatment, amount of drug used and how patient health and quality of life are impacted over time by the treatment.
Data will be collected from a retrospective and a prospective group of patients. Patients with submassive (Intermediate-High Risk) or massive (High Risk) pulmonary embolism who have undergone or planned to undergo the APT procedure will be screened for eligibility. Patients in the prospective arm will be treated according to the hospital standard of care. No experimental procedures are performed. After treatment with the APT procedure, patients will be followed up for up to 365 days post-procedure.Summary of Results
: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BcbW9wgc64X2JjNxW-2BqMpAMRQuUyJCzMC8GI33DyCFcBA-3D-3DBdyY_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIOc7WeKFpvUJPaMCnqOwGdlnlE-2Fn3MbId8-2B-2Bx-2B-2Fq-2F-2BjEY2P7TTPihX16UYIuCSh5nyBDqc9jJRGRPkzZD6bVzUXHnLEe3OJXCIIBxUsUK2yjpP5a9Hm9psLAWyXIdvzAa213H2K0JZcRkpYh1WVl5oVzLpxdA98owdU9fBXqWsNg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C6f68cd8af58242885c5808daef445961%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638085374079432463%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=VXw2HdLsFSvlL33%2F3MuQ5SP%2BSnW1VOFYKNy2IwRZzjY%3D&reserved=0
REC name
West of Scotland REC 5
REC reference
18/WS/0187
Date of REC Opinion
10 Oct 2018
REC opinion
Favourable Opinion