NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052190096

Registered date:27/01/2020

False lumen intervention

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedDissecting aneurysm of the aorta
Date of first enrollment11/03/2020
Target sample size15
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Entry closure located at the orifice including the neck vessels, visceral arteries, and the iliac arteries.

Outcome(s)

Primary OutcomeAortic diameter on CT at 12 months after intervention.
Secondary OutcomeOcclusive condition of the false lumen 12 months after intervention. Aortic diameter on CT and occlusive condition of the false lumen 6 and 24 months after intervention. Freedom from aortic rupture, re-aortic dissection, sudden death, and secondary intervention

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaPatients who had past history of undergoing the surgery for aortic dissection. Patients who developed aortic dilation more than 45mm in thoracic aortic aneurysm or more than 40mm in abdominal aortic aneurysm. Patients who developed rapid aortic dilation more than 3mm in 6 months or more than 5mm in 12months.
Exclude criteriaPatients who had systemic infection that may increase the risk of device-related infection. Patients who are allergic to the material of the device. Pregnant women, lactating women or women who cannot agree on contraception during participating in this study.

Related Information

Contact

Public contact
Name Yoshimasa Seike
Address 6-1 Kishibeshinmachi, Suita, Osaka Osaka Japan 564-8565
Telephone +81-6-6170-1070
E-mail ys46421g@ncvc.go.jp
Affiliation National Cerebral and Cardiovascular Center
Scientific contact
Name Hitoshi Matsuda
Address 6-1 Kishibeshinmachi, Suita, Osaka Osaka Japan 564-8565
Telephone +81-6-6170-1070
E-mail hitmat@mist.ocn.ne.jp
Affiliation National Cerebral and Cardiovascular Center