False lumen intervention

JRCT ID: jRCTs052190096

Registered date:27/01/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Dissecting aneurysm of the aorta
• Date of first enrollment: 11/03/2020
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Entry closure located at the orifice including the neck vessels, visceral arteries, and the iliac arteries.

Outcome(s)

• Primary Outcome: Aortic diameter on CT at 12 months after intervention.

Secondary Outcome

Occlusive 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 maximum: Not applicable
• Gender: Both

Include criteria

Patients 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 criteria

Patients 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

• Primary Sponsor: Matsuda Hitoshi