Viewing Study NCT03554850


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Study NCT ID: NCT03554850
Status: COMPLETED
Last Update Posted: 2022-05-27
First Post: 2018-05-23
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Trevo® Retriever Registry (China)
Sponsor: Stryker Neurovascular
Organization:

Study Overview

Official Title: Trevo® Retriever Registry (China)
Status: COMPLETED
Status Verified Date: 2022-05
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: None
Brief Summary: Trevo® Retriever Registry (China) is to assess real world performance of the FDA cleared Trevo Retriever intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke in China.
Detailed Description: Trevo Registry (China) is a prospective, open-label, multi-center study, and it is the first Stryker China trial. This trial assesses real world performance of the Trevo® Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in subjects experiencing ischemic stroke. Total of 200 subjects among up to 15 sites in China local will participate in this trial. The primary endpoint is revascularization status assessment at the end of the procedure using the modified TICI score.

Study Oversight

Has Oversight DMC: None
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?: True
Is an FDA AA801 Violation?: