Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-08 @ 12:03 AM
Study NCT ID:
NCT06041594
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2023-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Sponsor:
Innova Vascular, Inc.
Organization:
Study Overview
Official Title:
Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)
Status:
RECRUITING
Status Verified Date:
2025-04
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:
TRUST
Brief Summary:
This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.
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?:
False
Is an FDA AA801 Violation?: