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Aprospective, multicentre, single-arm clinical trial in which approximately 36 subjects would be enrolled using the Bridge 4.5 mm and 5.0 mm stent in accordance with the inclusion and exclusion criteria in this protocol. The success rate of immediate post-procedure stent target lesion treatment was recorded for all subjects, and the incidence of in-stent restenosis (≥50% stenosis) was assessed by DSA imaging follow-up at 6 months (±30 days) post-procedure. The subjects were also followed up at 30 days (±7 days), 6 months (±30 days), and 12 months (±60 days) after stent implantation to assess safety events during the follow-up period. .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Bridge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bridge | Device | Stent implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of in-stent restenosis at 6 months postoperatively | 180±30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | DSA suggesting residual stenosis ≤20% after implantation | post-implantation immediately |
| Any death or stroke during the follow-up associated with treatment in the target vessel supply region |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huina Lu | Contact | 15901703529 | HuiNa.Lu@microport.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Affilicated to Captical Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D014715 | Vertebrobasilar Insufficiency |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
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Number of participants with death or stroke related to treatments for target vessel blood supply area
| 1 year after stent implantation |
| Any death or stroke | Number of participants with death or stroke | 1 year after stent implantation |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |