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The Higher-risk Pulmonary Embolism Thrombolysis Study (HIGHER-PEITHO): A randomized trial of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute intermediate-high-risk pulmonary embolism

Head of Study:

Professor Stavros Konstantinides, MD

Professor Kenneth Rosenfield, MD

ClinicalTrials.gov Identifier: NCT04790370
https://clinicaltrials.gov/ct2/show/NCT04790370

 

 Summary

The HI-PEITHO study has been designed to address a critical gap in clinical evidence in PE by comparing the clinical benefit of intervention with EKOS vs. the current standard of care – anticoagulation. This trial is the largest and first of its kind in PE. It is designed to generate the most rigorous, highest level of data, contributing to the body of evidence for the treatment and outcomes in acute, intermediate-high risk PE. In addition, HI-PEITHO aims to advance the understanding of intermediate-high risk PE and risk stratification, to better identify patients who may clinically benefit from intervention, expanding access to care for these patients.

HI-PEITHO is a multi-center, prospective, randomized, controlled trial in the U.S. and Europe that will compare the outcomes of ultrasound-facilitated, catheter-directed, thrombolysis plus anticoagulation vs. anticoagulation alone for the treatment of acute, intermediate-high risk pulmonary embolism (PE).

Further information on the study can be found on the website of Boston Scientific.

Study Type

Interventional

Study Design

Post-market, randomized, controlled, adaptive, open-label, multicenter parallel-group trial with blinded adjudication of the primary composite outcome

Official Title

The Higher-risk Pulmonary Embolism Thrombolysis Study (HIGHER-PEITHO): A randomized trial of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis for acute intermediate-high-risk pulmonary embolism

Status

Recruiting

Steering Committee

Stavros Konstantinides, Irene Schmidtmann, Kenneth Rosenfield, Stefano Barco, Frederikus Klok, Gregory Piazza, Keith M. Sterling, Victor M. D. Tapson, Nils Kucher, Akhilesh Sista, Irene M. Lang, Andrew Sharp, Samuel Zachary Goldhaber

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