Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary E… (NCT06453876) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism (STRATIFY II)
Denmark210 participantsStarted 2026-05-01
Plain-language 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 AlphaVAC(R), AngioDynamics or the Flow Triever® system, INARI medical), Low intravenous thrombolysis (Alteplase 10 mg) 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 low-dose alteplase) 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 low-dose alteplase (2nd co-primary outcome)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 18 years
✓. Intermediate high-risk PE according to ESC criteria
✓. Class II risk assessed by the Pulmonary Embolism Severity Index (1).
✓. Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
✓. 14 days of symptoms or less, with significant worsening of symptoms within 7 days
Exclusion criteria
✕. Altered mental state (GCS \< 14)
✕. No qualifying CT angiography performed (\> 24 hour since CT angiography)
✕. Women of childbearing potential, unless negative HCG test is present.
✕. Thrombolysis for PE within 14 days of randomization
✕. Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
What they're measuring
1
Thrombus burdon reduction (intervention vs. heparin)