Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 8:03 AM
Study NCT ID:
NCT02040259
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2014-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trevo® Retriever Registry Post Market Surveillance
Sponsor:
Stryker Neurovascular
Organization:
Study Overview
Official Title:
Stryker Neurovascular Trevo® Retriever Registry
Status:
COMPLETED
Status Verified Date:
2020-06
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:
The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
Detailed Description:
Trevo Retriever Registry is a prospective, open-label, consecutive enrollment, multi-center, international registry that may enroll a maximum of 2000 patients at up to 100 sites worldwide. Revascularization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in Cerebral Infarction)score. Additional data collection will include:
1. Day 90 mRS assessment
2. Day 90 all cause mortality
3. Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score
4. Rates of device and procedure related serious adverse events (AEs)
1. Day 90 mRS assessment
2. Day 90 all cause mortality
3. Neurological deterioration at 24 hours post procedure, defined as a four or more point increase in the NIHSS score from the baseline score
4. Rates of device and procedure related serious adverse events (AEs)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: