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Comparison of Two Pulmonary Embolism Treatments

Primary Purpose

Pulmonary Embolism Acute

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anticoagulation
mechanical aspiration thrombectomy
Sponsored by
Penumbra Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism Acute focused on measuring intermediate-high risk, acute, PE, clot

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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 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 Patients on chronic antiplatelet or anticoagulation therapy, except low-dose acetylsalicylic acid or clopidogrel 75 mg once daily Cardiovascular or pulmonary surgery within last 7 days 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 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.

Sites / Locations

  • McLaren Bay Heart & VascularRecruiting
  • Cooper Health SystemRecruiting
  • Ascension Saint Thomas HospitalRecruiting
  • Sentara Norfolk General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anticoagulation (AC)

Indigo

Arm Description

Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.

Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.

Outcomes

Primary Outcome Measures

Change in RV/LV ratio
Change in RV/LV ratio at 48 hours on original therapy as assessed by computerized tomography pulmonary angiogram (CTPA)

Secondary Outcome Measures

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
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.
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-IV, with higher classifications being worse.
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.
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.
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.
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 6 dimensions, with higher scores being worse.
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 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
All-cause mortality within 90 days
PE-related Mortality
PE-related mortality within 90 days
Symptomatic PE Recurrence
Symptomatic PE recurrence within 90 days

Full Information

First Posted
December 16, 2022
Last Updated
September 26, 2023
Sponsor
Penumbra Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05684796
Brief Title
Comparison of Two Pulmonary Embolism Treatments
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism Acute
Keywords
intermediate-high risk, acute, PE, clot

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anticoagulation (AC)
Arm Type
Active Comparator
Arm Description
Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.
Arm Title
Indigo
Arm Type
Active Comparator
Arm Description
Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
Intervention Type
Drug
Intervention Name(s)
Anticoagulation
Intervention Description
Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
Intervention Type
Device
Intervention Name(s)
mechanical aspiration thrombectomy
Other Intervention Name(s)
Indigo Aspiration System
Intervention Description
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Primary Outcome Measure Information:
Title
Change in RV/LV ratio
Description
Change in RV/LV ratio at 48 hours on original therapy as assessed by computerized tomography pulmonary angiogram (CTPA)
Time Frame
48 hours post-randomization
Secondary Outcome Measure Information:
Title
Major Adverse Events
Description
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
Time Frame
within 7 days post-randomization
Title
Functional Outcome Assessment with the 6-minute walk test
Description
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.
Time Frame
within 90 days post-randomization
Title
Functional Outcome Assessment with the New York Heart Association Classification
Description
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.
Time Frame
within 90 days post-randomization
Title
Functional Outcome Assessment with the Post Venous Thromboembolism Functional Status scale
Description
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.
Time Frame
within 90 days post-randomization
Title
Functional Outcome Assessment with the modified Medical Research Council Dyspnea Scale
Description
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.
Time Frame
within 90 days post-randomization
Title
Functional Outcome Assessment with the Borg Scale
Description
Functional outcome as assessed by the Borg Scale through 90 days. The Borg Scale ranges from 0-10, with higher scores being worse.
Time Frame
within 90 days post-randomization
Title
Quality of Life Assessment with the Pulmonary Embolism Quality of Life Questionnaire
Description
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.
Time Frame
within 90 days post-randomization
Title
Quality of Life Assessment with the EQ-5D-5L Questionnaire
Description
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.
Time Frame
within 90 days post-randomization
Title
All-cause Mortality
Description
All-cause mortality within 90 days
Time Frame
within 90 days post-randomization
Title
PE-related Mortality
Description
PE-related mortality within 90 days
Time Frame
within 90 days post-randomization
Title
Symptomatic PE Recurrence
Description
Symptomatic PE recurrence within 90 days
Time Frame
within 90 days post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 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 Patients on chronic antiplatelet or anticoagulation therapy, except low-dose acetylsalicylic acid or clopidogrel 75 mg once daily Cardiovascular or pulmonary surgery within last 7 days 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Beatty
Phone
757-759-2898
Email
mbeatty@penumbrainc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Archard
Phone
802-377-9715
Email
earchard@penumbrainc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Rosovsky, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Lookstein, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLaren Bay Heart & Vascular
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Individual Site Status
Recruiting
Facility Name
Cooper Health System
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascension Saint Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Comparison of Two Pulmonary Embolism Treatments

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