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Thrombectomy Device
Patients with acute pulmonary embolism for Pulmonary Embolism
N/A
Recruiting
Led By John Moriarty, MD
Research Sponsored by Penumbra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 365 days
Awards & highlights
Summary
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
Eligible Conditions
- Pulmonary Embolism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 365 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Performance: Change in RV/LV Ratio
Safety: Composite of major adverse events
Secondary outcome measures
Any-cause mortality
Functional outcome assessed NYHA
Functional outcome assessed via 6MWT
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Patients with acute pulmonary embolismExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indigo Aspiration System
2019
N/A
~640
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Who is running the clinical trial?
Penumbra Inc.Lead Sponsor
36 Previous Clinical Trials
9,010 Total Patients Enrolled
2 Trials studying Pulmonary Embolism
219 Patients Enrolled for Pulmonary Embolism
John Moriarty, MDPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
234 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
234 Patients Enrolled for Pulmonary Embolism
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