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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
INCLUSION CRITERIA
1. Age ≥ 18 years
2. Intermediate high-risk PE according to ESC criteria
3. Class II risk assessed by the Pulmonary Embolism Severity Index (1).
4. Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
5. 14 days of symptoms or less, with significant worsening of symptoms within 7 days
EXCLUSION CRITERIA
1. Altered mental state (GCS \< 14)
2. No qualifying CT angiography performed (\> 24 hour since CT angiography)
3. Women of childbearing potential, unless negative HCG test is present.
4. Thrombolysis for PE within 14 days of randomization
5. Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
6. Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
7. Comorbidity making 6 months survival unlikely.
8. Absolute contraindications for thrombolysis:
1. History of haemorrhagic stroke or stroke of unknown origin
2. Ischaemic stroke in previous 6 months
3. Central nervous system neoplasm
4. Major trauma, surgery, or head injury in previous 3 weeks
5. Bleeding diathesis - Active bleeding
Primary outcome measure(s)
Thrombus burdon reduction (intervention vs. heparin) — To end of inclusion + 96 hours Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous treated groups (embolectomy and low dose thrombolysis) to heparin/LMWH alone group, p\<0.01 (n=140 vs. n=70)
Thrombus burdon reduction (USAT vs. embolektomy) — To end of inclusion + 96 hours Reduction in modified Miller score (score of thrombus involvement and segmental flow) comparing percutaneous embolectomy and low dose thrombolysis, p\<0.04 (n=70 vs n=70)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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