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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
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Evaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients.
This is a prospective, randomized, concurrent controlled, multi-center study. Patients with carotid artery stenosis will be assigned to either the Timing Carotid Stent or Carotid Wallstent. Each treated patient will be followed and assessed for 12 months after randomization. The hypothesis to be tested is that the safety and effectiveness of the Timing Carotid Stent is not inferior to the Carotid Wallstent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timing Carotid Stent | Experimental |
| |
| Carotid Wallstent | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing Carotid Stent | Device | all the participants in this group will be performed with Timing Carotid Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced Major Adverse Events (MAE) at 30 days | MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Stent Technical Success | Stent Technical Success defined as successful implantation of a Carotid Stent | Procedural |
| Number of Participants Who Achieved Procedure Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D016893 | Carotid Stenosis |
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Carotid Wallstent | Device | all the participants in this group will be performed with Carotid Wallstent |
|
Number of Participants Who Achieved Procedure Success
| Procedural |
| Target Lesion Revascularization | Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion | 30 days |
| In-Stent Restenosis | ≥50% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation | 1 year |
| Ipsilateral ischemic stroke | Any ipsilateral ischemic stroke through 1 year post-index procedure | 1 year |
| mRS score change | mRS score change through 1 year post-index procedure | 1 year |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001157 | Arterial Occlusive Diseases |