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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05684796
Registration number
NCT05684796
Ethics application status
Date submitted
16/12/2022
Date registered
13/01/2023
Date last updated
18/06/2025
Titles & IDs
Public title
Comparison of Two Pulmonary Embolism Treatments
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Scientific 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
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Secondary ID [1]
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18190
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism Acute
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Anticoagulation
Treatment: Devices - mechanical aspiration thrombectomy
Active comparator: Anticoagulation (AC) - Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.
Active comparator: Indigo - Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
Treatment: Drugs: Anticoagulation
Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Treatment: Devices: mechanical aspiration thrombectomy
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in RV/LV ratio
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Assessment method [1]
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Change in RV/LV ratio at 48 hours on original therapy as assessed by computerized tomography pulmonary angiogram (CTPA)
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Timepoint [1]
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48 hours post-randomization
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Secondary outcome [1]
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Major Adverse Events
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Assessment method [1]
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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
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Timepoint [1]
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within 7 days post-randomization
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Secondary outcome [2]
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Functional Outcome Assessment with the 6-minute walk test
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Assessment method [2]
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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.
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Timepoint [2]
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within 90 days post-randomization
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Secondary outcome [3]
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Functional Outcome Assessment with the New York Heart Association Classification
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Assessment method [3]
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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-IV, with higher classifications being worse.
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Timepoint [3]
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within 90 days post-randomization
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Secondary outcome [4]
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Functional Outcome Assessment with the Post Venous Thromboembolism Functional Status scale
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Assessment method [4]
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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.
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Timepoint [4]
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within 90 days post-randomization
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Secondary outcome [5]
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Functional Outcome Assessment with the modified Medical Research Council Dyspnea Scale
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Assessment method [5]
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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.
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Timepoint [5]
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within 90 days post-randomization
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Secondary outcome [6]
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Functional Outcome Assessment with the Borg Scale
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Assessment method [6]
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Functional outcome as assessed by the Borg Scale through 90 days. The Borg Scale ranges from 0-10, with higher scores being worse.
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Timepoint [6]
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within 90 days post-randomization
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Secondary outcome [7]
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Quality of Life Assessment with the Pulmonary Embolism Quality of Life Questionnaire
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Assessment method [7]
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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 6 dimensions, with higher scores being worse.
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Timepoint [7]
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within 90 days post-randomization
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Secondary outcome [8]
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Quality of Life Assessment with the EQ-5D-5L Questionnaire
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Assessment method [8]
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Quality of Life (QoL), as assessed by the EQ-5D-5L Questionnaire through 90 days. The EQ-5D-5L Questionnaire measures 5 dimensions, with higher scores being worse. The Visual Analogue Scale (VAS) scale is part of the questionnaire and ranges from 0-100, with higher scores being better.
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Timepoint [8]
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within 90 days post-randomization
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Secondary outcome [9]
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All-cause Mortality
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Assessment method [9]
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All-cause mortality within 90 days
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Timepoint [9]
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within 90 days post-randomization
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Secondary outcome [10]
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PE-related Mortality
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Assessment method [10]
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PE-related mortality within 90 days
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Timepoint [10]
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within 90 days post-randomization
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Secondary outcome [11]
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Symptomatic PE Recurrence
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Assessment method [11]
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Symptomatic PE recurrence within 90 days
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Timepoint [11]
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within 90 days post-randomization
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
100
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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Arizona
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California
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United States of America
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Florida
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United States of America
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Georgia
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Illinois
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State/province [6]
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Kentucky
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United States of America
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Maryland
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Michigan
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New Jersey
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New York
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Texas
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United States of America
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Virginia
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Country [13]
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Canada
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State/province [13]
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Alberta
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Country [14]
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New Zealand
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State/province [14]
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Auckland
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Country [15]
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Poland
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State/province [15]
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Kraków
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Penumbra Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/study/NCT05684796
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rachel Rosovsky, MD
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Address
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Massachusetts General Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Meghan Beatty
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Address
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Country
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Phone
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757-759-2898
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Fax
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Email
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mbeatty@penumbrainc.com
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05684796
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