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Percutaneous Embolectomy, Ultrasound Assisted Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism
Sponsor: Jesper Kjaergaard
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)
Official title: Percutaneous Embolectomy, Ultrasund Assisted Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2025-06-01
Completion Date
2029-10-31
Last Updated
2025-04-04
Healthy Volunteers
No
Conditions
Interventions
Ultrasound assisted Thrombolysis
Please see Arms
Percutaneous Embolectomy
Please see arms
Heparin
Active comparator
Locations (4)
Copenhagen University Hospital Gentofte
Gentofte Municipality, Capital Region, Denmark
Copenhagen University Hospital Bispebjerg Hospital
Bispebjerg, Denmark
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Copenhagen University Hospital, Herlev Gentofte Hospital
Herlev, Denmark