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STRATIFY II
EU CTIS ID: 2024-515712-45-00
What this study is testing
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 or The AlphaVac® system, Angiodynamics), loww 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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join 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)
See the full eligibility criteria
- 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
- 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 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.