Comparison of Two Pulmonary Embolism Treatments

About

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).

Primary Purpose

Treatment

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

80 Years

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
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
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.
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