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

JRCT ID: jRCT1040210075

Registered date:28/09/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: abdominal aortic aneurysm or iliac arterial aneurysm
• Date of first enrollment: 28/09/2021
• Target sample size: 144
• Study type: Interventional
• Intervention(s): coil embolization to the inferior mesenteric artery before endovascular aneurysm repair

Outcome(s)

• Primary Outcome: occurence of type II endoleak

Secondary Outcome

Following 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 maximum: Not applicable
• Gender: Both
• 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

• Primary Sponsor: Kato Noriyuki