NIPH Clinical Trials Search

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) studiedfusiform or saccular aneurysms
Date of first enrollment2011/05/01
Target sample size50
Countries of recruitmentJapan,North America,Europe
Study typeInterventional
Intervention(s)Stent graft custody with catheter


Primary OutcomeDevice 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 minimum20years-old
Age maximumNot applicable
GenderMale 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


public contact
Name Yasuhito Shimizu
Address Nakano Central Park East, Nakano 4-10-1, Nakano, Tokyo, Japan Japan
Telephone 03-6853-9450
Affiliation Cook Japan Incorporated Clinical Affairs
scientific contact
Name Cook Incorporated
Address 750 Daniels Way, Bloomington, IN 47404 US
Telephone +1-800-346-2235
Affiliation Cook Incorporated Regulatory Affairs