Clinical trial NCT05684796: Comparison of Two Pulmonary Embolism Treatments
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Embolism Acute
Keywords: intermediate-high risk
acute
PE
clot
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in RV/LV ratio
timeFrame: 48 hours post-randomization
Secondary outcomes:
measure: Major Adverse Events
timeFrame: within 7 days post-randomization
measure: Functional Outcome Assessment with the 6-minute walk test
timeFrame: within 90 days post-randomization
measure: Functional Outcome Assessment with the New York Heart Association Classification
timeFrame: within 90 days post-randomization
measure: Functional Outcome Assessment with the Post Venous Thromboembolism Functional Status scale
timeFrame: within 90 days post-randomization
measure: Functional Outcome Assessment with the modified Medical Research Council Dyspnea Scale
timeFrame: within 90 days post-randomization
measure: Functional Outcome Assessment with the Borg Scale
timeFrame: within 90 days post-randomization
measure: Quality of Life Assessment with the Pulmonary Embolism Quality of Life Questionnaire
timeFrame: within 90 days post-randomization
measure: Quality of Life Assessment with the EQ-5D-5L Questionnaire
timeFrame: within 90 days post-randomization
measure: All-cause Mortality
timeFrame: within 90 days post-randomization
measure: PE-related Mortality
timeFrame: within 90 days post-randomization
measure: Symptomatic PE Recurrence
timeFrame: within 90 days post-randomization
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona - Banner
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Lakeland
country: United States
facility: Radiology and Imaging Specialists/Lakeland Regional
state: Florida
city: Decatur
country: United States
facility: Joseph Maxwell Cleland Atlanta VA Medical Center
state: Georgia
city: Marietta
country: United States
facility: Wellstar Kennestone
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Edgewood
country: United States
facility: St. Elizabeth Edgewood Hospital
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Bay City
country: United States
facility: McLaren Bay Heart & Vascular
state: Michigan
city: Royal Oak
country: United States
facility: Corewell Health William Beaumont University Hospital
state: Michigan
city: Camden
country: United States
facility: Cooper Health System
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Austin
country: United States
facility: Ascension Seton Medical Center Austin
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: San Antonio
country: United States
facility: Metropolitan Methodist Hospital
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Kraków
country: Poland
facility: Krakowski Szpital Specjalistyczny św. Jana Pawła II
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel Rosovsky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Robert Lookstein, MD
role: PRINCIPAL_INVESTIGATOR
References: