Trials / Completed
CompletedNCT05496361
A Prospective, Multi-center and Randomized Controlled Trial of Tianyi Revascularization Device in Acute Ischemic Stroke
A Prospective, Multi-center and Randomized Controlled Clinical Trial to Assess the Safety and Effectiveness of Tianyi Revascularization Device of in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 238 (actual)
- Sponsor
- Suzhou Zenith Vascular Scitech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation.
Detailed description
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation will be assigned to either the Tianyi Revascularization Device or Solitaire FR Revascularization Device. Each treated patient will be followed and assessed for 3 months after randomization. Up to 238 evaluable patients at up to 18 centers presenting with acute ischemic stroke in vessels accessible to the Revascularization Device for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Tianyi Revascularization Device for the revascularization of large vessel occlusion is not inferior to the Solitaire FR Revascularization Device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tianyi Revascularization Device | Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain |
| DEVICE | Solitaire FR Revascularization Device | Revascularization Device using the Mechanical thrombectomy technique for recanalization of an occlusion large vessel in the brain |
Timeline
- Start date
- 2021-01-24
- Primary completion
- 2021-11-24
- Completion
- 2022-07-20
- First posted
- 2022-08-11
- Last updated
- 2022-08-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05496361. Inclusion in this directory is not an endorsement.