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Comparison of Two Pulmonary Embolism Treatments

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ClinicalTrials.gov Identifier: NCT05684796
Recruitment Status : Recruiting
First Posted : January 13, 2023
Last Update Posted : June 3, 2024
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Tracking Information
First Submitted Date  ICMJE December 16, 2022
First Posted Date  ICMJE January 13, 2023
Last Update Posted Date June 3, 2024
Actual Study Start Date  ICMJE November 27, 2023
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2023)
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 computerized tomography pulmonary angiogram (CTPA)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2023)
  • Major Adverse Events [ Time Frame: within 7 days post-randomization ]
    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
  • Functional Outcome Assessment with the 6-minute walk test [ Time Frame: within 90 days post-randomization ]
    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.
  • Functional Outcome Assessment with the New York Heart Association Classification [ Time Frame: within 90 days post-randomization ]
    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.
  • Functional Outcome Assessment with the Post Venous Thromboembolism Functional Status scale [ Time Frame: within 90 days post-randomization ]
    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.
  • Functional Outcome Assessment with the modified Medical Research Council Dyspnea Scale [ Time Frame: within 90 days post-randomization ]
    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.
  • Functional Outcome Assessment with the Borg Scale [ Time Frame: within 90 days post-randomization ]
    Functional outcome as assessed by the Borg Scale through 90 days. The Borg Scale ranges from 0-10, with higher scores being worse.
  • Quality of Life Assessment with the Pulmonary Embolism Quality of Life Questionnaire [ Time Frame: within 90 days post-randomization ]
    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.
  • Quality of Life Assessment with the EQ-5D-5L Questionnaire [ Time Frame: within 90 days post-randomization ]
    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.
  • All-cause Mortality [ Time Frame: within 90 days post-randomization ]
    All-cause mortality within 90 days
  • PE-related Mortality [ Time Frame: within 90 days post-randomization ]
    PE-related mortality within 90 days
  • Symptomatic PE Recurrence [ Time Frame: within 90 days post-randomization ]
    Symptomatic PE recurrence within 90 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Pulmonary Embolism Treatments
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Embolism Acute
Intervention  ICMJE
  • Drug: Anticoagulation
    Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
  • Device: mechanical aspiration thrombectomy
    Mechanical aspiration thrombectomy with the Indigo Aspiration System.
    Other Name: Indigo Aspiration System
Study Arms  ICMJE
  • Active Comparator: Anticoagulation (AC)
    Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.
    Intervention: Drug: Anticoagulation
  • Active Comparator: Indigo
    Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
    Intervention: Device: mechanical aspiration thrombectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2023)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2026
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Active cancer or cancer/tumor requiring active therapy (surgery, chemotherapy, targeted therapy, or radiation) in the previous 6 months or during the course of the trial (other than non-melanoma skin cancer) or tumor with caval invasion
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Meghan Beatty 757-759-2898 mbeatty@penumbrainc.com
Contact: Erin Archard 802-377-9715 earchard@penumbrainc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05684796
Other Study ID Numbers  ICMJE 18190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Penumbra Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Penumbra Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rachel Rosovsky, MD Massachusetts General Hospital
Principal Investigator: Robert Lookstein, MD MOUNT SINAI HOSPITAL
PRS Account Penumbra Inc.
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP