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Comparison of Two Pulmonary Embolism Treatments

NCT05684796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-17

No results posted yet for this study

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

Interventions

DRUG

Anticoagulation

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

DEVICE

mechanical aspiration thrombectomy

Mechanical aspiration thrombectomy with the Indigo Aspiration System.

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • Rachel Rosovsky, MD · Massachusetts General Hospital

  • Robert Lookstein, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2025-06-12
Completion
2025-09-09
FDA Device
Yes

Countries

  • United States
  • Canada
  • New Zealand
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05684796 on ClinicalTrials.gov