Overview

Percutaneous Embolectomy, Ultrasound Assisted Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism

Status:
NOT_YET_RECRUITING

Trial end date:
2029-10-31

Target enrollment:

Participant gender:

Summary

The STRATIFY II trial investigates the efficacy of three different approaches to reducing thrombus burdon in patients with acute intermediate high-risk pulmonary embolism: percutaneous embolectomy (the Flow Triever® system, INARI medical), USAT (EKOS® system, Boston Scientific with low dose alteplase) and heparin with the option to perform full-dose thrombolysis. As a co-primary secondary end point the trial assess the incremental efficacy of the embolectomy vs the catheter based low dose thrombolysis approach. Thus the two main hypothesis being tested are: 1. Thrombus burden reduction after 48-96 h is increased with a catheter based (embolectomy or USAT) compared to the a heparin with optional high dose thrombolysis approach (1st co-primary outcome) 2. Thrombus burden reduction after 48-96 h is increased with percutaneous embolectomy compared to USAT with low-dose alteplase (2nd co-primary outcome)

Phase:

PHASE3

Details

Lead Sponsor:

Jesper Kjaergaard

Collaborators:

Copenhagen University Hospital at Herlev
Zealand University Hospital

Treatments:

Heparin
Heparin, Low-Molecular-Weight