Comparison of Two Pulmonary Embolism Treatments

NCT05684796 | Completed DMC FDA Device

• 1 other identifier: 18190
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 22

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).

Conditions

Pulmonary Embolism Acute

Keywords

intermediate-high risk; acute; PE; clot

Outcome Measures

Primary Outcomes (1)

• Change in RV/LV ratio

  Change in RV/LV ratio at 48 hours on original therapy as assessed by computerized tomography pulmonary angiogram (CTPA)

  48 hours post-randomization

Secondary Outcomes (11)

• Major Adverse Events

  within 7 days post-randomization

• Functional Outcome Assessment with the 6-minute walk test

  within 90 days post-randomization

• Functional Outcome Assessment with the New York Heart Association Classification

  within 90 days post-randomization

• Functional Outcome Assessment with the Post Venous Thromboembolism Functional Status scale

  within 90 days post-randomization

• Functional Outcome Assessment with the modified Medical Research Council Dyspnea Scale

  within 90 days post-randomization

Study Arms (2)

Anticoagulation (AC)

ACTIVE COMPARATOR

Subjects will have their pulmonary embolism treated with anticoagulants alone. There will be no procedure for this group.

Drug: Anticoagulation

Indigo

ACTIVE COMPARATOR

Subjects will have their pulmonary embolism treated with anticoagulants and mechanical aspiration thrombectomy with the Indigo® Aspiration System.

Device: mechanical aspiration thrombectomy

Interventions

Anticoagulation DRUG

Anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH)

Anticoagulation (AC)

mechanical aspiration thrombectomy DEVICE

Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Also known as: Indigo Aspiration System

Indigo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (22)

The University of Arizona - Banner

Tucson, Arizona, 85719, United States

Location

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Radiology and Imaging Specialists/Lakeland Regional

Lakeland, Florida, 33801, United States

Location

Joseph Maxwell Cleland Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Wellstar Kennestone

Marietta, Georgia, 30060, United States

Location

Northwestern Memorial

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

St. Elizabeth Edgewood Hospital

Edgewood, Kentucky, 41017, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

McLaren Bay Heart & Vascular

Bay City, Michigan, 48708, United States

Location

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Cooper Health System

Camden, New Jersey, 08103, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Ascension Seton Medical Center Austin

Austin, Texas, 78705, United States

Location

Baylor University Medical Center

Dallas, Texas, 75226, United States

Location

Kingwood Medical Center

Kingwood, Texas, 77339, United States

Location

Metropolitan Methodist Hospital

San Antonio, Texas, 78212, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Auckland City Hospital

Auckland, New Zealand

Location

Krakowski Szpital Specjalistyczny św. Jana Pawła II

Krakow, Poland

Location

Related Publications (2)

• Lookstein RA, Konstantinides SV, Weinberg I, Dohad SY, Rosol Z, Kopec G, Moriarty JM, Parikh SA, Holden A, Channick RN, McDonald B, Nagarsheth KH, Yamada K, Rosovsky RP; STORM-PE Trial Investigators. Randomized Controlled Trial of Mechanical Thrombectomy With Anticoagulation Versus Anticoagulation Alone for Acute Intermediate-High Risk Pulmonary Embolism: Primary Outcomes From the STORM-PE Trial. Circulation. 2026 Jan 6;153(1):21-34. doi: 10.1161/CIRCULATIONAHA.125.077232. Epub 2025 Nov 3.

  PMID: 41183181 DERIVED

• Rosovsky RP, Konstantinides SV, Moriarty JM, Dohad SY, Weinberg I, Parikh SA, Channick R, Lookstein RA. A prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study. Am Heart J. 2025 Oct;288:1-14. doi: 10.1016/j.ahj.2025.03.018. Epub 2025 Mar 31.

  PMID: 40174693 DERIVED

Study Officials

• Rachel Rosovsky, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Robert Lookstein, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will be 1:1 to either anticoagulation alone (AC Group) or anticoagulation plus mechanical aspiration thrombectomy with the Indigo Aspiration System (Indigo Group).

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: January 13, 2023
• Study Start: November 27, 2023
• Primary Completion: June 12, 2025
• Study Completion: September 9, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

PL (1); NZ (1); US (19); CA (1)