A Prospective Study of Prevention of Aneurysm Diameter Enlargement after Endovascular Aortic Repair of Abdominal Aortic Aneurysm by Side Branch Embolization Using Preoperative 4D Flow MRI Analysis

JRCT ID: jRCT1042210068

Registered date:13/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Abdominal Aortic Aneurysm
• Date of first enrollment: 13/09/2021
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Side branch embolization will be performed in cases where the mass side banch blood flow is above the cutoff value on the preoperative 4D Flow MRI examination, according to the method specified in the study plan.

Outcome(s)

Primary Outcome

Abdominal aortic aneurysm with or without increase in aneurysm diameter at 1 year after surgery.
(Enlargement of more than 5 mm in maximum short diameter on CT)

• Secondary Outcome: Presence of Type II endoleaks at 1 year after surgery

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with a diagnosis of abdominal aortic aneurysm scheduled to undergo treatment with endovascular aortic repair.
As a historical control, patients who visited Hamamatsu University School of Medicine Hospital between January 1, 2013 and March 31, 2021, were diagnosed with abdominal aortic aneurysm and underwent endovascualr aortic repair, and who underwent 4D flow MRI before surgery.

Exclude criteria

1. emergency surgery(rupture,threatened rupture)
2. renal dysfunction(eGFR below 30ml/min)
3. people who can not give consent (for example,people who have claustrophobia)
4. people who can not take MRI(contrast media allergy,devices which is unsupported for MRI such as cochlea implant,artificial joint,pacemaker)
5.the researcher judges that participation in this research is inappropriate

Related Information

• Primary Sponsor: Sano Masaki