Comparison of Two Pulmonary Embolism Treatments
- Conditions
- Pulmonary Embolism Acute
- Interventions
- Drug: AnticoagulationDevice: mechanical aspiration thrombectomy
- Registration Number
- NCT05684796
- Lead Sponsor
- Penumbra Inc.
- 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 available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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)
-
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
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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
-
<45 mL/min creatinine clearance
-
Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
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Active bleeding or disorders contraindicating anticoagulant therapy
-
Hemoglobin <10 g/dL
-
Platelets <100,000/μL
-
INR >3
-
Cardiovascular or pulmonary surgery within last 7 days
-
Primary brain or metastatic brain cancer
-
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
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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.
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anticoagulation (AC) Anticoagulation Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group. Indigo mechanical aspiration thrombectomy Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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 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 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.
Symptomatic PE Recurrence within 90 days post-randomization Symptomatic PE recurrence within 90 days
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
Trial Locations
- Locations (19)
Krakowski Szpital Specjalistyczny św. Jana Pawła II
🇵🇱Kraków, Poland
The University of Arizona - Banner
🇺🇸Tucson, Arizona, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Radiology and Imaging Specialists/Lakeland Regional
🇺🇸Lakeland, Florida, United States
Wellstar Kennestone
🇺🇸Marietta, Georgia, United States
Northwestern Memorial
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
McLaren Bay Heart & Vascular
🇺🇸Bay City, Michigan, United States
Cooper Health System
🇺🇸Camden, New Jersey, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Ascension Seton Medical Center Austin
🇺🇸Austin, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Kingwood Medical Center
🇺🇸Kingwood, Texas, United States
Metropolitan Methodist Hospital
🇺🇸San Antonio, Texas, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Auckland City Hospital
🇳🇿Auckland, New Zealand