UMIN ID: UMIN000055302
Registered date:01/10/2024
SENTINEL Cerebral Protection System post marketing surveillance study
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Thromboembolism |
| Date of first enrollment | 2024/12/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Occurrence rate of all stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) though 30 days post TAVR procedure |
|---|---|
| Secondary Outcome | -Modified Rankin Scale (mRS) at baseline, post-procedure, 30 days post procedure and AE for stroke -SAE for which relation to SENTINEL Cerebral Protection System or procedures cannot be denied during the follow-up period -Device malfunction and adverse event for which the relation to SENTINEL Cerebral Protection System or procedures cannot be denied during the follow-up period -Anti-platelet medication and anti- coagulation medication usage from the procedure through 30 days post procedure. |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Not applicable |
Related Information
| Primary Sponsor | Boston Scientific Japan K.K. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Boston Scientific Japan K.K. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroshi Sakamoto |
| Address | 4-10-2 Nakano, Nakano-ku, Tokyo, Japan Japan 164-0001 |
| Telephone | 03-6853-7500 |
| Hiroshi.Sakamoto@bsci.com | |
| Affiliation | Boston Scientific Japan K.K. Clinical Sciences |
| scientific contact | |
| Name | Kazuo Kawahara |
| Address | 4-10-2 Nakano, Nakano-ku, Tokyo, Japan Japan |
| Telephone | 03-6853-7500 |
| Kazuo.Kawahara@bsci.com | |
| Affiliation | Boston Scientific Japan K.K. Clinical Sciences |