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| Name | Class |
|---|---|
| Kobe City General Hospital | OTHER |
| Juntendo University | OTHER |
| Kyoto University | OTHER |
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This trial is conducted to evaluate the safety and technical effectiveness of using NCVC-CS1, a newly developed honeycomb microporous covered stent, for the treatment of intracranial aneurysms which are difficult to be cured by conventional surgical or endovascular procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | neuroendovascular therapy(NCVC-CS1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCVC-CS1 | Device | Intervention Description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation: Any stroke or death related to the procedure within 180 days | 180 days after the procedure | |
| Efficacy evaluation: Complete obliteration of target aneurysm and patency of target vessel (less than 50% stenosis) confirmed by angiography at 180 days after the procedure | 180 days after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success (stent placement in the target lesion covering aneurysmal neck without occlusion of target vessel) | 180 days after the procedure | |
| Any death within 180 days after the procedure | 180 days after the procedure |
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Inclusion Criteria:
(Provisional registration)
Age between 20 and 75 years.
Target lesion is an unruptured aneurysm regardless of prior treatment diagnosed by angiography, CTA, or MRA within 180 days
Modified Rankin score of 3 or less
Agreement for participating in the study and informed consent signed by the patient.
(definitive registration)
1. Target lesion must be reconfirmed by angiography or interventional procedure and is compatible with the conditions as follows:
Exclusion Criteria:
(Provisional registration)
(definitive registration)
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| Name | Affiliation | Role |
|---|---|---|
| Tetsu Satow | National Cerebral and Cardiovascular Center, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobe City General Hospital | Kobe | Hyōgo | 650-0047 | Japan | ||
| National Cerebral and Cardiovascular Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31072845 | Derived | Yamamoto H, Hamasaki T, Onda K, Nakayama Y, Ishii A, Oishi H, Sakai N, Satow T. Evaluating the safety and technical effectiveness of a newly developed intravascular 'flow isolator' stent for the treatment of intracranial aneurysms: study protocol for a first-in-human single-arm multiple-site clinical trial in Japan. BMJ Open. 2019 May 9;9(5):e020966. doi: 10.1136/bmjopen-2017-020966. |
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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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| Any death by neurological reason within 180 days after the procedure | 180 days after the procedure |
| Any adverse event or adverse device effect | 180 days after the procedure |
| Neurological assessment (scale ; mRS) | 180 days after the procedure |
| Neurological assessment (scale ; Barthel Index) | 180 days after the procedure |
| Neurological assessment (scale ; NIHSS) | 30 days after the procedure |
| Neurological assessment (scale ; GCS) | 30 days after the procedure |
| Suita |
| Osaka |
| 565-8565 |
| Japan |
| Juntendo University Hospital | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Kyoto University Hospital | Kyoto | 6068507 | Japan |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |