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The purpose of this study is to assess how safe choydar flow-directed mesh stent is and how well it works in the treatment of unruptured intracranial aneurysms (a condition in which a bulging blood vessel in the brain can burst and cause bleeding) in a real-world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Choydar Flow-Directed Mesh Stent | The choydar flow-directed mesh stent will be used in accordance to its Instructions For Use (IFU) in participants with unruptured intracranial aneurysms. Participants will not receive any other intervention as a part of this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Complete Aneurysm Occlusion Rate at 12 Months Post-Procedure (Raymond-Roy Class I) | Complete aneurysm occlusion rate as per Raymond Roy classification criteria (Class I) is defined as complete obliteration (no contrast filling in aneurysm body or neck). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation * 100 percent (%). | At 12 months follow-up post-procedure |
| Adequate Aneurysm Occlusion Rate at 12-month Follow-up Post-Procedure (Raymond-Roy Classes I and II) | Adequate aneurysm occlusion rate as per Raymond Roy classification criteria (Class II and III) is defined as Class II: residual neck (contrast filling in aneurysm neck but none in aneurysm body) and Class III: residual aneurysm (contrast filling in aneurysm body). It is calculated as follows: number of target aneurysms achieving Raymond-Roy Class I/II occlusion at 12-month follow-up post-procedure/number of target aneurysms with 12-month imaging evaluation * 100 %. | At 12 months follow-up post-procedure |
| Percentage of Participants with Immediate Technical Success Rate of Procedure | Percentage of participants with immediate technical success rate of procedure will be reported. Immediate technical success of the procedure is defined as the percentage of participants in whom the flow diverter is successfully deployed during the procedure, with accurate positioning confirmed by intra-procedure angiography, and with effective coverage of the aneurysm neck by the implant. It is calculated as follows: number of participants with successful placement of the investigational device/total number of participants undergoing the treatment * 100 %. | At Day 0 (Day of procedure) |
| Re-treatment Rate of Target Aneurysm at 12-Month Follow-up Post-Procedure | The incidence of re-treatment of the target aneurysm at 12 months follow-up post-procedure will be reported. |
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Inclusion criteria:
Participants meeting all the following inclusion criteria will be included:
Preoperative inclusion criteria:
Intraoperative inclusion criteria:
- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by DSA during the procedure, wide-neck (neck width >= 4 mm or dome-to-neck ratio <2) saccular or fusiform aneurysms, and the parent artery diameter must be >= 2.0 mm and <= 6.0 mm
Exclusion criteria:
Participants meeting any of the following exclusion criteria will be excluded:
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Adult participants with unruptured wide-neck (neck width >= 4 mm or dome-to-neck ratio <2) saccular or fusiform aneurysms in the internal carotid artery (from the petrous segment to the distal end) and the vertebral artery arising from a parent vessel with a diameter >= 2.0 mm and <= 6.0 mm.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanyuan Gu | Contact | 86 15692105615 | ygu51@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Medical (Shanghai) Ltd. Clinical Trial | Johnson & Johnson Medical (Shanghai) Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chenzhou No.1 People's Hospital | Recruiting | Chenzhou | 432000 | China | ||
| Guangdong Provincial People's Hospital |
The data sharing policy of Johnson & Johnson MedTech is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| At 12 months follow-up post-procedure |
| Percentage of Participants with Modified Rankin Scale (mRS) Score of 0-2 at 12 Months Post-Procedure | Percentage of participants with mRS score of 0-2 at 12 months post-procedure will be reported. The mRS score is issued to evaluate the improvement of neurological function. It assesses the ability of participants with neurological disease to live independently. There are 7 levels of this score, 0 points represent no symptoms of disability, higher scores mean worse prognosis of participants , and 6 points represent death. | At 12 months follow-up post-procedure |
| Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During Perioperative Period | Number of participants with major ischemic/hemorrhagic events and/or death during perioperative period will be reported. Major ischemic/hemorrhagic events are defined as an increase of >= 4 points in the National Institutes of Health Stroke Scale (NIHSS) score compared with the previous score. | Perioperative |
| Number of Participants with Major Ischemic/Hemorrhagic Events and/or Death During 12-Month Follow-up | Number of participants with major ischemic/hemorrhagic events and/or death during 12 months follow-up period will be reported. Major ischemic/hemorrhagic events are defined as an increase of >= 4 points in the NIHSS score compared with the previous score. | At 12 months follow-up post-procedure |
| Number of Participants with Severe in-Stent Stenosis (Greater Than [>] 50%) During 12-Month Follow-up | Number of participants with severe in-stent stenosis during 12-month follow-up period will be reported. The percent stenosis is calculated according to the calculation method of Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study as follows: (1 - Ds [Diameter of the artery at the site of the most severe stenosis]/Dn [Diameter of the normal artery]) * 100%. | At 12 months follow-up post-procedure |
| Rupture Rate of Target Aneurysm During 12-Month Follow-Up Post-Procedure | The incidence of rupture of the target aneurysm within 12 months post-procedure will be reported. | At 12 months follow-up post-procedure |
| Recruiting |
| Guangzhou |
| 519041 |
| China |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Recruiting | Nanjing | 210008 | China |
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | 210029 | China |
| Nanyang Central Hospital | Recruiting | Nanyang | 473000 | China |
| Shanxi Provincial People's Hospital | Recruiting | Taiyuan | 30012 | China |
| The First Affiliated Hospital of Wannan Medical College | Recruiting | Wuhu | 241001 | China |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | 450052 | China |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |