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JAPANESE
国立保健医療科学院
JRCT ID: jRCT1040210075

Registered date:28/09/2021

Randomized controlled trial for inferior meseteric artery embolization before endovascular aneurysm repair

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedabdominal aortic aneurysm or iliac arterial aneurysm
Date of first enrollment28/09/2021
Target sample size144
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)coil embolization to the inferior mesenteric artery before endovascular aneurysm repair

Outcome(s)

Primary Outcomeoccurence of type II endoleak
Secondary OutcomeFollowing events observed during follow-up (1) aneurysm growth by >= 5 mm (2) additional intervention (3) adverse event related with IMA embolization and EVAR

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria(1) an abdominal aortic anuerysm or an iliac arterial aneurysm which requires intervention, (2) anatomically suitable for endovascular aneurys repair, (3) IMA is patent, (4) IMA orifice cannot be closed by a main body device, (5) 20 years old or older, (6) preserved renal function without hemodialysis (eGFR >30ml/min/1.73m^2), or on hemodialysis, (7) patients' signed consent to the study after sufficient explanation
Exclude criteria(1) ruptured aneurysm, (2) infectious aneurysm, (3) hireditary connective tissue disease, (4) allergy to contrast medium, (5) allergy to metal, (6) patient who the investigators judge as inappropriate

Related Information

Contact

Public contact
Name Noriyuki Kato
Address 2-174 Edobashi, Tsu, Mie Mie Japan 514-8507
Telephone +81-59-231-5029
E-mail nkato@med.mie-u.ac.jp
Affiliation Mie University Hospital
Scientific contact
Name Noriyuki Kato
Address 2-174 Edobashi, Tsu, Mie Mie Japan 514-8507
Telephone +81-59-231-5029
E-mail nkato@med.mie-u.ac.jp
Affiliation Mie University Hospital