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NOT YET RECRUITING
NCT06453876
PHASE3

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

Sponsor: Jesper Kjaergaard

View on ClinicalTrials.gov

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

Interventions

DEVICE

Ultrasound assisted Thrombolysis

Please see Arms

DEVICE

Percutaneous Embolectomy

Please see arms

DRUG

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