Trevo® Retriever Registry (China)

Stryker

Status: Completed

Conditions: Real World Data in China

Treatments: Device: Trevo® Retriever

Study type: Observational

Funder types: Industry

Identifiers

NCT03554850

CDM10001400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18
2. Subjects experiencing acute ischemic stroke due to a large vessel occlusion who are eligible and suitable for restoration of blood flow using any approved Trevo Retriever in the neurovasculature to remove thrombus
3. Trevo Retriever is planned to be the primary mechanical neuro-thrombectomy device to remove the thrombus
4. Subject or subject's legally authorized Representative (LAR) has signed the study Informed Consent Form
5. Subject willing to comply with the protocol follow-up requirements

Exclusion criteria

1. mRS >2
2. Any known coagulopathy
3. Anticipated life expectancy less than 3 months
4. Known absolute contraindications to the use of required study medications or agents (e.g., heparin, aspirin, clopidogrel, radiographic contrast agents, etc.)
5. Preexisting neurological or psychiatric disease that would prevent complete the study required evaluations
6. 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