NCT02040259

Trevo® Retriever Registry Post Market Surveillance

Stryker Neurovascular Trevo® Retriever Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,008 (actual)
• Sponsor: Stryker Neurovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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)

Conditions

• Ischemic Stroke

Timeline

• Start date: 2013-11-25
• Primary completion: 2017-12-28
• Completion: 2017-12-28
• First posted: 2014-01-20
• Last updated: 2020-06-24
• Results posted: 2020-06-24

Locations

80 sites across 12 countries: United States, Canada, Czechia, France, Germany, Hungary, Italy, Singapore, South Korea, Spain, Switzerland, Thailand