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Taking peoplePhase 4

Comparing clot removal, clot-dissolving drug or heparin for lung blood clots

Compares clot removal, alteplase and heparin for pulmonary embolism.

Key facts

Who runs it
Rigshospitalet
Where
Denmark4 sites in 1 countryChoose a country to see its sites
Registry title
STRATIFY II
Status
Recruiting
Phase
Phase 4
People taking part
210 people, planned
Started
1 Jul 2026
Expected to end
31 Dec 2031
Type of study
Interventional
Record updated
22 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Age ≥ 18 years
  • Intermediate high-risk pulmenary embolism according to ESC criteria
  • 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
  • Class II risk assessed by the Pulmonary Embolism Severity Index

Who cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The STRATIFY II trial investigates the efficacy of three different approaches to reducing thrombus burden in patients with acute intermediate high-risk pulmonary embolism: percutaneous embolectomy (the Flow Triever® system, INARI medical, The AlphaVac® system, Angiodynamics or Lightning Flash 2.0/3.0, Penumbra), low dose (10 mg ov over 6 hours) alteplase and heparin with the option to perform full-dose thrombolysis. As a co-primary secondary endpoint, the trial assesses the incremental efficacy of the embolectomy versus the catheter-based low dose thrombolysis approach.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

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Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
PERCUTANEOUS EMBOLECTOMY, LOW DOSE THROMBOLYSIS OR HEPARIN FOR INTERMEDIATE HIGH RISK PULMONARY EMBOLISM
Plain-language title
Comparing clot removal, clot-dissolving drug or heparin for lung blood clotsGenerated from the registry record. The registry title is the official one.
Record updated
22 October 2026