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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
13/12/2024

Titles & IDs
Public title
Comparison of Two Pulmonary Embolism Treatments
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
Secondary ID [1] 0 0
18190
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism Acute 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in RV/LV ratio
Timepoint [1] 0 0
48 hours post-randomization
Secondary outcome [1] 0 0
Major Adverse Events
Timepoint [1] 0 0
within 7 days post-randomization
Secondary outcome [2] 0 0
Functional Outcome Assessment with the 6-minute walk test
Timepoint [2] 0 0
within 90 days post-randomization
Secondary outcome [3] 0 0
Functional Outcome Assessment with the New York Heart Association Classification
Timepoint [3] 0 0
within 90 days post-randomization
Secondary outcome [4] 0 0
Functional Outcome Assessment with the Post Venous Thromboembolism Functional Status scale
Timepoint [4] 0 0
within 90 days post-randomization
Secondary outcome [5] 0 0
Functional Outcome Assessment with the modified Medical Research Council Dyspnea Scale
Timepoint [5] 0 0
within 90 days post-randomization
Secondary outcome [6] 0 0
Functional Outcome Assessment with the Borg Scale
Timepoint [6] 0 0
within 90 days post-randomization
Secondary outcome [7] 0 0
Quality of Life Assessment with the Pulmonary Embolism Quality of Life Questionnaire
Timepoint [7] 0 0
within 90 days post-randomization
Secondary outcome [8] 0 0
Quality of Life Assessment with the EQ-5D-5L Questionnaire
Timepoint [8] 0 0
within 90 days post-randomization
Secondary outcome [9] 0 0
All-cause Mortality
Timepoint [9] 0 0
within 90 days post-randomization
Secondary outcome [10] 0 0
PE-related Mortality
Timepoint [10] 0 0
within 90 days post-randomization
Secondary outcome [11] 0 0
Symptomatic PE Recurrence
Timepoint [11] 0 0
within 90 days post-randomization

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)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Penumbra Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel Rosovsky, MD
Address 0 0
Massachusetts General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Meghan Beatty
Address 0 0
Country 0 0
Phone 0 0
757-759-2898
Fax 0 0
Email 0 0
mbeatty@penumbrainc.com
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