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Thrombectomy Device

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

N/A
Recruiting
Led By Andrew Sharp, 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 90 days post-procedure
Awards & highlights
No Placebo-Only Group

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 weeks
Treatment ~ Varies
Follow Up ~90 days post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Performance: Change in RV/LV Ratio
Safety: Composite of major adverse events
Secondary study objectives
Functional outcome assessed NYHA
Functional outcome assessed via 6MWT
Perceived dyspnea assessed via Borg Scale
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Find a Location

Who is running the clinical trial?

Penumbra Inc.Lead Sponsor
36 Previous Clinical Trials
8,951 Total Patients Enrolled
2 Trials studying Pulmonary Embolism
219 Patients Enrolled for Pulmonary Embolism
Andrew Sharp, MDPrincipal InvestigatorUniversity College Dublin and The Mater Misericordiae Hospital
1 Previous Clinical Trials
128 Total Patients Enrolled
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
~508 spots leftby Dec 2026
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