Comparison of Two Pulmonary Embolism Treatments
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Anticoagulation (AC) Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. |
Drug: Anticoagulation
Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)
|
| Active Comparator: Indigo Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System. |
Device: mechanical aspiration thrombectomy
Mechanical aspiration thrombectomy with the Indigo Aspiration System.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in RV/LV ratio [48 hours post-randomization]
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 [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 [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 [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 [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 [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 [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 [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 [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 [within 90 days post-randomization]
All-cause mortality within 90 days
- PE-related Mortality [within 90 days post-randomization]
PE-related mortality within 90 days
- Symptomatic PE Recurrence [within 90 days post-randomization]
Symptomatic PE recurrence within 90 days
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-80 years old
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Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
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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
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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
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Jugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration System
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Informed consent is obtained from either the patient or legally authorized representative (LAR)
Exclusion Criteria:
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Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imaging
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Hemodynamic instability with any of the following present:
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Cardiac arrest
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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
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Patients on ECMO
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National Early Warning Score (NEWS) 2 ≥9
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History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
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Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
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Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
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Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
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Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
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Active bleeding or disorders contraindicating anticoagulant therapy
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Hemoglobin <10 g/dL
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Platelets <100,000/μL
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INR >3
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Patients on chronic antiplatelet or anticoagulation therapy, except low-dose acetylsalicylic acid or clopidogrel 75 mg once daily
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Cardiovascular or pulmonary surgery within last 7 days
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Stage III/IV cancer or cancer or tumor which requires active chemotherapy or radiation therapy during the course of the trial
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Life expectancy <90 days
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Pregnancy
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Intracardiac thrombus (right atrium, right ventricle clot in transit) identified on baseline imaging
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Penumbra Inc.
Investigators
- Principal Investigator: Rachel Rosovsky, MD, Massachusetts General Hospital
- Principal Investigator: Robert Lookstein, MD, MOUNT SINAI HOSPITAL
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18190