Comparison of Two Pulmonary Embolism Treatments

Study Overview
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Brief Summary
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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
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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

Conditions
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Pulmonary Embolism Acute

Intervention / Treatment
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* Drug: Anticoagulation
* Device: mechanical aspiration thrombectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anticoagulation (AC)<br>Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. | Drug: Anticoagulation<br>* Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)<br>|
| Active Comparator: Indigo<br>Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. | Device: mechanical aspiration thrombectomy<br>* Mechanical aspiration thrombectomy with the Indigo Aspiration System.<br>* Other names: Indigo Aspiration System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in RV/LV ratio | Change in RV/LV ratio at 48 hours on original therapy as assessed by computerized tomography pulmonary angiogram (CTPA) | 48 hours post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within 7 days post-randomization | 
| 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. | within 90 days post-randomization | 
| 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. | within 90 days post-randomization | 
| 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. | within 90 days post-randomization | 
| 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. | within 90 days post-randomization | 
| 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. | within 90 days post-randomization | 
| 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. | within 90 days post-randomization | 
| 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. | within 90 days post-randomization | 
| All-cause Mortality | All-cause mortality within 90 days | within 90 days post-randomization | 
| PE-related Mortality | PE-related mortality within 90 days | within 90 days post-randomization | 
| Symptomatic PE Recurrence | Symptomatic PE recurrence within 90 days | within 90 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermediate-high risk, acute, PE, clot