Anticoagulation Alone vs Anticoagulation Plus Mechanical Aspiration With the Indigo Aspiration System in Pulmonary Embolism

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of a device called the Indigo Aspiration System in combination with anticoagulants for the treatment of pulmonary embolism (PE) compared to treatment with anticoagulants only. A PE is a blood clot in an artery or arteries in the lung. Anticoagulants are given to stop blood clots from forming and to treat existing blood clots. The Indigo Aspiration System is approved by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, excluding the head, and for the treatment of PE. The Indigo Aspiration System is a type of aspiration thrombectomy, which is a device that sucks the clot(s) out of the patient’s body via a small tube that is placed in the blood vessel(s) and navigated to the blocked artery in the lung. Patients will be randomly assigned to 1 of 2 groups: treatment with the Indigo System in combination with anticoagulants, or treatment with anticoagulants only. Other procedures include blood draws, obtaining images of lungs, administering questionnaires, a walking test, and medical records review.

Eligibility

1. Age 18-80 years old
2. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
3. 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
4. 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

Inclusion Criteria:

1. Age 18-80 years old
2. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
3. 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
4. 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
5. Jugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration System
6. Informed consent is obtained from either the patient or legally authorized representative (LAR)

Exclusion Criteria:

1. Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imaging
2. Hemodynamic instability with any of the following present:
1. Cardiac arrest
2. 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
3. Patients on ECMO
4. National Early Warning Score (NEWS) 2 ≥9
5. History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
6. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
7. Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
8. Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicated
9. \<45 mL/min creatinine clearance
10. Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
11. Active bleeding or disorders contraindicating anticoagulant therapy
12. Hemoglobin \<10 g/dL
13. Platelets \<100,000/μL
14. INR \>3
15. Cardiovascular or pulmonary surgery within last 7 days
16. Primary brain or metastatic brain cancer
17. Life expectancy \<90 days
18. Pregnancy
19. Intracardiac thrombus (right atrium, right ventricle clot in transit) or thrombus in the inferior vena cava identified on baseline imaging
20. 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.
21. 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

Show less

Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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 Details

Disease Type/Condition

Other

Principal Investigator

Matusov, Yuri

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002616

ClinicalTrials.gov ID

NCT05684796

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org