Pulmonary Embolism AcuteNCT05684796
Comparison of Two Pulmonary Embolism Treatments
A study testing Anticoagulation and mechanical aspiration thrombectomy in people with Pulmonary Embolism Acute, run by Penumbra Inc. at 22 sites in 4 countries.
Trial summary
The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism Acute
- What is being tested?
- Anticoagulation and mechanical aspiration thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 27 Nov 2023to 9 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- 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
- 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
- Jugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration System
- Informed consent is obtained from either the patient or legally authorized representative (LAR)
Who cannot join
- Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imaging
- Hemodynamic instability with any of the following present:
- Cardiac arrest
- 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
- Patients on ECMO
- National Early Warning Score (NEWS) 2 ≥9
Show all 23Show fewer
- History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
- Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
- Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
- <45 mL/min creatinine clearance
- Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
- Active bleeding or disorders contraindicating anticoagulant therapy
- Hemoglobin <10 g/dL
- Platelets <100,000/μL
- INR >3
- Cardiovascular or pulmonary surgery within last 7 days
- Primary brain or metastatic brain cancer
- Life expectancy <90 days
- Pregnancy
- Intracardiac thrombus (right atrium, right ventricle clot in transit) or thrombus in the inferior vena cava identified on baseline imaging
- 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.
- 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
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
United States19 sites
Ascension Seton Medical Center Austin
Austin, Texas, 78705
University of Maryland
Baltimore, Maryland, 21201
McLaren Bay Heart & Vascular
Bay City, Michigan, 48708
Cooper Health System
Camden, New Jersey, 08103
Northwestern Memorial
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Baylor University Medical Center
Dallas, Texas, 75226
Joseph Maxwell Cleland Atlanta VA Medical Center
Decatur, Georgia, 30033
St. Elizabeth Edgewood Hospital
Edgewood, Kentucky, 41017
Kingwood Medical Center
Kingwood, Texas, 77339
Radiology and Imaging Specialists/Lakeland Regional
Lakeland, Florida, 33801
UCLA Medical Center
Los Angeles, California, 90024
Cedars Sinai Medical Center
Los Angeles, California, 90048
Wellstar Kennestone
Marietta, Georgia, 30060
Mount Sinai Hospital
New York, New York, 10029
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073
Metropolitan Methodist Hospital
San Antonio, Texas, 78212
The University of Arizona - Banner
Tucson, Arizona, 85719
About this study
Official title: 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
The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).
- Conditions
- Pulmonary Embolism Acute
- Being tested
- Anticoagulation, mechanical aspiration thrombectomy
- Keywords
- intermediate-high risk, acute, PE, clot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticoagulationDrug
Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
mechanical aspiration thrombectomyDevice
Also called Indigo Aspiration System
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation (AC) | Active comparator | Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Receives: Drug: Anticoagulation |
| Indigo | Active comparator | Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. Receives: Device: mechanical aspiration thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in RV/LV Ratio
Change in RV/LV ratio at 48 hours on original therapy as assessed by computed tomography pulmonary angiography (CTPA). Negative change values represent a reduction in the ratio of right ventricular to left ventricular diameter, consistent with improvement in right ventricular dilation.
Measured: 48 hours post-randomization
Secondary outcomes (11)
Major Adverse Events
Major adverse events (MAEs) within 7 days: a composite of clinical deterioration requiring escalation of care, PE-related mortality, symptomatic recurrent PE, or major bleeding
Measured: within 7 days post-randomization
Functional Outcome Assessment With the 6-minute Walk Test
Functional outcome as assessed by the 6-minute walk test (6MWT) through 90 days. The 6-minute walk test measures distance walked in meters, with longer distances being better.
Measured: Through 90 days post-randomization
Functional Outcome Assessment With the New York Heart Association Classification
Functional outcome as assessed by the New York Heart Association classification (NYHA) through 90 days. The New York Heart Association classification ranges from Class I (no limitations) -IV (severe limitation), with higher classifications being worse.
Measured: Through 90 days post-randomization
Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale
Functional outcome as assessed by the Post Venous Thromboembolism Functional Status (PVFS) scale through 90 days. The Post Venous Thromboembolism Functional Status scale ranges from 0-5, with higher scores being worse.
Measured: Through 90 days post-randomization
Functional Outcome Assessment With the Modified Medical Research Council Dyspnea Scale
Functional outcome as assessed by the modified Medical Research Council Dyspnea Scale (mMRC) through 90 days. The modified Medical Research Council Dyspnea Scale ranges from 0-4, with higher scores being worse.
Measured: Through 90 days post-randomization
Functional Outcome Assessment With the Borg Scale
Functional outcome as assessed by the Borg Scale through 90 days. The Borg Scale ranges from 0-10, with higher scores being worse.
Measured: Through 90 days post-randomization
Quality of Life Assessment With the Pulmonary Embolism Quality of Life Questionnaire
Quality of Life (QoL), as assessed by the Pulmonary Embolism Quality of Life Questionnaire (PEmb-QoL) through 90 days. The Pulmonary Embolism Quality of Life Questionnaire measures the percent of life affected by PE across 6 dimensions (including: Frequency of complaints, Limitations in activities of daily living (ADL), Work-related problems, Social limitations, Intensity of complaints, Emotional complaints), with higher scores being worse.
Measured: Through 90 days post-randomization
Quality of Life Assessment With the EQ-5D-5L Questionnaire
Quality of Life (QoL), as assessed by the EQ-5D-5L Questionnaire through 90 days. The EQ-5D-5L index is a preference-weighted measure of health status derived from five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Index values represent overall health status, with higher scores indicating better health status.
The Visual Analogue Scale (VAS) scale is part of the questionnaire and ranges from 0-100, with higher scores being better.
Measured: Through 90 days post-randomization
All-cause Mortality
All-cause mortality within 90 days
Measured: within 90 days post-randomization
PE-related Mortality
PE-related mortality within 90 days
Measured: within 90 days post-randomization
Symptomatic PE Recurrence
Symptomatic PE recurrence within 90 days
Measured: within 90 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start27 Nov 2023
- Primary completion12 Jun 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Embolism AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be 1:1 to either anticoagulation alone (AC Group) or anticoagulation plus mechanical aspiration thrombectomy with the Indigo Aspiration System (Indigo Group).
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Rosovsky, MD, Principal investigator, Massachusetts General HospitalRobert Lookstein, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684796
- Sponsor's protocol ID
- 18190
- Status last verified
- Jul 2026
- First submitted
- 16 Dec 2022
- Last updated
- 18 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Rosovsky RP, Konstantinides SV, Weinberg I, Dohad SY, Rosol Z, Stepniewski J, Moriarty JM, Parikh SA, Holden A, Channick RN, McDonald B, Nagarsheth KH, Matusov Y, Lookstein RA; STORM-PE Trial Investigators and Collaborators. Mechanical Thrombectomy Versus Anticoagulation Alone in Intermediate-High Risk PE: Improved Functional 90-Day Outcomes in STORM-PE RCT. JACC Cardiovasc Interv. 2026 Oct 5:S1936-8798(26)02391-5. doi: 10.1016/j.jcin.2026.07.042. Online ahead of print.
PubMed 42836810Lookstein RA, Konstantinides SV, Weinberg I, Dohad SY, Rosol Z, Kopec G, Moriarty JM, Parikh SA, Holden A, Channick RN, McDonald B, Nagarsheth KH, Yamada K, Rosovsky RP; STORM-PE Trial Investigators. Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Outcomes From the STORM-PE Trial. Circulation. 2026 Jan 6;153(1):21-34. doi: 10.1161/CIRCULATIONAHA.125.077232. Epub 2025 Nov 3.
PubMed 41183181Rosovsky RP, Konstantinides SV, Moriarty JM, Dohad SY, Weinberg I, Parikh SA, Channick R, Lookstein RA. A prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study. Am Heart J. 2025 Oct;288:1-14. doi: 10.1016/j.ahj.2025.03.018. Epub 2025 Mar 31.
PubMed 40174693
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05684796
- Acronym / sponsor ID
- 18190
- Conditions
- Pulmonary Embolism Acute
- Keywords
- intermediate-high risk, acute, PE, clot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Posted 18 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization will be 1:1 to either anticoagulation alone (AC Group) or anticoagulation plus mechanical aspiration thrombectomy with the Indigo Aspiration System (Indigo Group).
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation (AC) | Active comparator | Drug: AnticoagulationSubjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. |
| Indigo | Active comparator | Device: mechanical aspiration thrombectomySubjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years old
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- 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
- 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
- Jugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration System
Key exclusion criteria (23 listed)
- Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imaging
- Hemodynamic instability with any of the following present:
- Patients on ECMO
- National Early Warning Score (NEWS) 2 ≥9
- History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnticoagulationAnticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH) | Drug | Anticoagulation (AC) |
| mechanical aspiration thrombectomyAlso: Indigo Aspiration SystemMechanical aspiration thrombectomy with the Indigo Aspiration System. | Device | Indigo |
Primary outcome
Change in RV/LV Ratio
Time frame: 48 hours post-randomization
Change in RV/LV ratio at 48 hours on original therapy as assessed by computed tomography pulmonary angiography (CTPA). Negative change values represent a reduction in the ratio of right ventricular to left ventricular diameter, consistent with improvement in right ventricular dilation.
11 secondary outcomes
Major Adverse Events
Time frame: within 7 days post-randomization
Functional Outcome Assessment With the 6-minute Walk Test
Time frame: Through 90 days post-randomization
Functional Outcome Assessment With the New York Heart Association Classification
Time frame: Through 90 days post-randomization
Functional Outcome Assessment With the Post Venous Thromboembolism Functional Status Scale
Time frame: Through 90 days post-randomization
Functional Outcome Assessment With the Modified Medical Research Council Dyspnea Scale
Time frame: Through 90 days post-randomization
Functional Outcome Assessment With the Borg Scale
Time frame: Through 90 days post-randomization
Quality of Life Assessment With the Pulmonary Embolism Quality of Life Questionnaire
Time frame: Through 90 days post-randomization
Quality of Life Assessment With the EQ-5D-5L Questionnaire
Time frame: Through 90 days post-randomization
All-cause Mortality
Time frame: within 90 days post-randomization
PE-related Mortality
Time frame: within 90 days post-randomization
Symptomatic PE Recurrence
Time frame: within 90 days post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42836810Rosovsky RP, Konstantinides SV, Weinberg I, Dohad SY, Rosol Z, Stepniewski J, Moriarty JM, Parikh SA, Holden A, Channick RN, McDonald B, Nagarsheth KH, Matusov Y, Lookstein RA; STORM-PE Trial Investigators and Collaborators. Mechanical Thrombectomy Versus Anticoagulation Alone in Intermediate-High Risk PE: Improved Functional 90-Day Outcomes in STORM-PE RCT. JACC Cardiovasc Interv. 2026 Oct 5:S1936-8798(26)02391-5. doi: 10.1016/j.jcin.2026.07.042. Online ahead of print.
- Derived from this study: PubMed 41183181Lookstein RA, Konstantinides SV, Weinberg I, Dohad SY, Rosol Z, Kopec G, Moriarty JM, Parikh SA, Holden A, Channick RN, McDonald B, Nagarsheth KH, Yamada K, Rosovsky RP; STORM-PE Trial Investigators. Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Outcomes From the STORM-PE Trial. Circulation. 2026 Jan 6;153(1):21-34. doi: 10.1161/CIRCULATIONAHA.125.077232. Epub 2025 Nov 3.
- Derived from this study: PubMed 40174693Rosovsky RP, Konstantinides SV, Moriarty JM, Dohad SY, Weinberg I, Parikh SA, Channick R, Lookstein RA. A prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study. Am Heart J. 2025 Oct;288:1-14. doi: 10.1016/j.ahj.2025.03.018. Epub 2025 Mar 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Rosovsky, MD principal investigator
Massachusetts General Hospital
Robert Lookstein, MD principal investigator
MOUNT SINAI HOSPITAL
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulation and mechanical aspiration thrombectomy in people with Pulmonary Embolism Acute, run by Penumbra Inc. at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Canada, New Zealand, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in RV/LV Ratio (time frame: 48 hours post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684796, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.