Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-03-29 @ 3:56 PM
Study NCT ID:
NCT03218566
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2017-07-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Sponsor:
Penumbra Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXTRACT-PE
Brief Summary:
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: