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Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism

NCT03218566 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2020-08-03

Study results available
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Summary

To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)

Conditions

Interventions

DEVICE

Indigo Aspiration System

use of mechanical thrombectomy to treat pulmonary embolism

Sponsors & Collaborators

  • Penumbra Inc.

    lead INDUSTRY

Principal Investigators

  • Akhilesh Sista, MD · NYU-Langone School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2019-03-10
Completion
2019-04-05
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03218566 on ClinicalTrials.gov