Percutaneous Embolectomy, Low Dose Thrombolysis or Heparin for Intermediate High Risk Pulmonary Embolism (STRATIFY II)

Recruiting now · Phase 3

Conditions studied: Pulmonary Embolism

In brief

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)

Key facts

Study ID

NCT06453876

Run by

Jesper Kjaergaard

People needed

210

Starts

2026-06-17

Expected to finish

2029-10-31

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)
• Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
• Comorbidity making 6 months survival unlikely.
• Absolute contraindications for thrombolysis:
• History of haemorrhagic stroke or stroke of unknown origin
• Ischaemic stroke in previous 6 months
• Central nervous system neoplasm
• Major trauma, surgery, or head injury in previous 3 weeks
• Bleeding diathesis - Active bleeding

Where it is running

• Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark (enrolling)
• Odense University Hospital — Odense, Denmark

Full record on ClinicalTrials.gov

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