Trevo® Retriever Registry Post Market Surveillance

Stryker

Status: Completed

Conditions: Ischemic Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT02040259

T4025

Details and patient eligibility

About

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.

Full 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)

Enrollment: 2,008 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects experiencing acute ischemic stroke who are eligible for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
• Trevo Retriever is the initial mechanical neuro-thrombectomy device used to remove the thrombus
• Signed Informed Consent obtained
• Subject willing to comply with the protocol follow-up requirements
• Anticipated life expectancy of at least 3 months

Exclusion criteria

• The subject is participating in another mechanical neuro-thrombectomy device trial or any other clinical trial where the study procedure or treatment might confound the study end point.

Trial design

2,008 participants in 1 patient group

Mechanical thrombectomy, Trevo Retriever

Description:

Mechanical thrombectomy, Trevo Retriever