UMIN ID: UMIN000005576
Registered date:11/05/2011
Zenih TX2; Low Profile TAA Endovascular Graft Clinical Study
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | fusiform or saccular aneurysms |
| Date of first enrollment | 2011/05/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan,North America,Europe |
| Study type | Interventional |
| Intervention(s) | Stent graft custody with catheter |
Outcome(s)
| Primary Outcome | Device success, Procedural time, Condit usage during the procedure, Clinical utility measures, Morbidity, including the composite rate of major adverse events, Endleak, change in aneurysm size, migration, device patency, device integrity |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | <General Exclusion Criteria> 1) Less than 20 years of age 2) Life expectancy less than 2 years 3) Pregnant or breastfeeding or planning on becoming pregnant within 60 months 4) Unwilling to company with the follow-up schedule 5) Inability or refusal to give informed consent 6) Less than 30 days beyond primary endpoint for other investigative drug or device study *Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too. |
Related Information
| Primary Sponsor | Cook Japan Incorporated |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Cook Incorporated |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yasuhito Shimizu |
| Address | Nakano Central Park East, Nakano 4-10-1, Nakano, Tokyo, Japan Japan |
| Telephone | 03-6853-9450 |
| cookjapan-com@umin.net | |
| Affiliation | Cook Japan Incorporated Clinical Affairs |
| scientific contact | |
| Name | Cook Incorporated |
| Address | 750 Daniels Way, Bloomington, IN 47404 US |
| Telephone | +1-800-346-2235 |
| Ted.Heise@cookmedical.com | |
| Affiliation | Cook Incorporated Regulatory Affairs |