COMPLETED

Comparison of Two Pulmonary Embolism Treatments

Conditions

Pulmonary Embolism Acute intermediate-high risk acute PE clot

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2023-11-27

Study Completion:2025-09-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05684796

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	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

Inclusion Criteria

Exclusion 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)

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

Contacts and Locations

Principal Investigator

Rachel Rosovsky, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Robert Lookstein, MD

PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Study Locations (Sites)

The University of Arizona - Banner

Tucson, Arizona, 85719

United States

UCLA Medical Center

Los Angeles, California, 90024

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Radiology and Imaging Specialists/Lakeland Regional

Lakeland, Florida, 33801

United States

Joseph Maxwell Cleland Atlanta VA Medical Center

Decatur, Georgia, 30033

United States

Wellstar Kennestone

Marietta, Georgia, 30060

United States

Northwestern Memorial

Chicago, Illinois, 60611

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

St. Elizabeth Edgewood Hospital

Edgewood, Kentucky, 41017

United States

University of Maryland

Baltimore, Maryland, 21201

United States

McLaren Bay Heart & Vascular

Bay City, Michigan, 48708

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

Cooper Health System

Camden, New Jersey, 08103

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Ascension Seton Medical Center Austin

Austin, Texas, 78705

United States

Baylor University Medical Center

Dallas, Texas, 75226

United States

Kingwood Medical Center

Kingwood, Texas, 77339

United States

Metropolitan Methodist Hospital

San Antonio, Texas, 78212

United States

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: Penumbra Inc.

Rachel Rosovsky, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital
Robert Lookstein, MD, PRINCIPAL_INVESTIGATOR, MOUNT SINAI HOSPITAL

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27

Study Completion Date2025-09-09

Study Record Updates

Study Start Date2023-11-27

Study Completion Date2025-09-09

Terms related to this study

Keywords Provided by Researchers

intermediate-high risk
acute
PE
clot

Additional Relevant MeSH Terms

Pulmonary Embolism Acute