Pulmonary Embolism: Safety and Outcomes of Indigo Aspiration System

What is the Purpose of this Study?

This study focuses on individuals who have had a pulmonary embolism (PE) and whose doctor has determined that the clot should be removed to prevent damage to the heart and lungs. A PE is a blood clot in an artery or arteries in the lung. The purpose of the study is to examine the effectiveness of the Indigo Aspiration System for treatment of pulmonary embolism. The Indigo Aspiration System is a medical device that has been cleared by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, except for the head. Researchers aim to collect information on how patients with PE recover after treatment with the Indigo Aspiration System.


Eligibility

  • Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
  • RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
  • Frontline endovascular treatment with the Indigo Aspiration System per IFU
  • Patient is ≥ 18 years of age
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

STRIKE-PE: A Prospective, Multicenter Study of the Indigo? Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

Study Details
Disease Type/Condition

Other

Principal Investigator

Dohad, Suhail

Age Group

Adult

Phase

IV

IRB Number

STUDY00001405

ClinicalTrials.gov ID

NCT04798261

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Details
Disease Type/Condition

Other

Principal Investigator

Dohad, Suhail

Age Group

Adult

Phase

IV

IRB Number

CLP18135

ClinicalTrials.gov ID

NCT04798261

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org