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Comparing two treatments for pulmonary embolism

STORM-PE: A Prospective, Multicenter, Randomized Controlled Trial Evaluating Anticoagulation Alone vs Anticoagulation Plus Mechanical Aspiration With the Indigo® Aspiration System for the Treatment of Intermediate High Risk Acute Pulmonary Embolism

Not applicable Interventional Penumbra Inc. · NCT05684796

This study tests whether a combination of blood thinners and a special device to remove blood clots works better than just blood thinners alone for people with serious pulmonary embolism.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorPenumbra Inc. Industry-sponsored
Locations19 sites (Tucson, Arizona and 18 other locations)
Trial IDNCT05684796 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate the safety and efficacy of two treatment approaches for intermediate-high risk acute pulmonary embolism: anticoagulation alone versus a combination of anticoagulation and mechanical aspiration thrombectomy using the Indigo Aspiration System. Participants will be assessed based on clinical signs, imaging results, and specific biomarkers to confirm their eligibility. The study will involve patients aged 18-80 who have been diagnosed with acute PE within the last 14 days and exhibit signs of right ventricular dysfunction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with confirmed acute pulmonary embolism and signs of right ventricular dysfunction.

Not a fit: Patients who have received thrombolytic agents or have hemodynamic instability may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from acute pulmonary embolism.

How similar studies have performed: Other studies have explored similar treatment approaches, but the specific combination of anticoagulation and mechanical aspiration thrombectomy is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age 18-80 years old
2. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
3. Objectively confirmed acute PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery
4. Classification of intermediate high-risk PE as demonstrated by right ventricular dysfunction with RV/LV ratio ≥1.0 on CTPA and elevated cardiac biomarkers, including cardiac troponin, BNP, and/or NT-pro BNP above the upper limit of normal
5. Jugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration System
6. Informed consent is obtained from either the patient or legally authorized representative (LAR)

Exclusion Criteria:

1. Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imaging
2. Hemodynamic instability with any of the following present:

   1. Cardiac arrest
   2. Obstructive shock or persistent hypotension defined as systolic blood pressure (BP) \<90 mmHg or an acute drop in systolic BP ≥40 mmHg for \>15 min, or requiring vasopressor or inotropic support to achieve a systolic BP ≥90 mmHg
3. Patients on ECMO
4. National Early Warning Score (NEWS) 2 ≥9
5. History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
6. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
7. Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
8. Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
9. \<45 mL/min creatinine clearance
10. Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
11. Active bleeding or disorders contraindicating anticoagulant therapy
12. Hemoglobin \<10 g/dL
13. Platelets \<100,000/μL
14. INR \>3
15. Cardiovascular or pulmonary surgery within last 7 days
16. Primary brain or metastatic brain cancer
17. Life expectancy \<90 days
18. Pregnancy
19. Intracardiac thrombus (right atrium, right ventricle clot in transit) or thrombus in the inferior vena cava identified on baseline imaging
20. Current participation in another investigational drug or device trial that may confound the results of this trial. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
21. Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the trial, including compliance with follow-up requirements, or that could impact the scientific integrity of the trial

Where this trial is running

Tucson, Arizona and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Embolism Acuteintermediate-high riskacutePEclot
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.