Unique ID issued by UMIN | UMIN000035502 |
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Receipt number | R000038758 |
Scientific Title | A multicenter randomized controlled trial to evaluate the efficacy of preemptive inferior mesenteric artery embolization during endovascular aortic aneurysm repair on aneurysm sac change: Clarify IMA |
Date of disclosure of the study information | 2019/02/01 |
Last modified on | 2023/07/14 12:28:09 |
Efficacy of preemptive inferior mesenteric artery embolization during endovascular aortic aneurysm repair
Clarify IMA
A multicenter randomized controlled trial to evaluate the efficacy of preemptive inferior mesenteric artery embolization during endovascular aortic aneurysm repair on aneurysm sac change: Clarify IMA
Clarify IMA
Japan | Europe |
Abdominal aortic aneurysm
Cardiology | Vascular surgery | Radiology |
Others
NO
To evaluate an efficacy of preemptive embolization of IMA during EVAR for reduction of persistent type II endoleak and following sac enlargement
Efficacy
Comparison of aneurysm sac change in both arms at 12M after EVAR
Rate of persistent type II endoleak at 6,12,24M
Comparison of aneurysm sac change and sac diameter change in both arms at 6,12,24M after EVAR
Rate of freedom from reintervention
Rate of freedom from aneurysm related death
Volume of contrast media usage
Radiation exposure
Device cost
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Maneuver |
Preemptive embolization of IMA during EVAR
Control
20 | years-old | <= |
Not applicable |
Male and Female
Aneurysm sac diameter >50mm or sac with rapid enlargement
IMA diameter >2.5mm
Age >20yo
Anatomical limitation of proximal neck as the followings
Diameter <28mm
Length >15mm
Infrarenal angulation <60 degree (If possible)
IMA diameter <2.5mm or occluded/stenotic orifice
IMA originates from the proximal neck
Under treatment for advanced malignant tumor
Life expectancy<1 year
Connective tissue disease such as Marfan syn.or Ehlers-Danlos syndrome
Mycotic aneurysm
Saccular aneurysm/ PAU(penetrating atherosclerotic ulcer)
Allergy for contrast media
Preoperative eGFR<30ml/dl and has not introduced hemodialysis
Pregnancy
Younger than 20 yo
200
1st name | Shigeo |
Middle name | |
Last name | Ichihashi |
Nara Medical University
Radiology
6348521
840 Shijocho, Kashihara, Nara
+81744298900
ichihash@naramed-u.ac.jp
1st name | Shigeo |
Middle name | |
Last name | Ichihashi |
Nara Medical University
Radiology
6348521
840 Shijocho, Kashihara, Nara
+81744298900
ichihash@naramed-u.ac.jp
Nara Medical University
W.L.Gore & Associates, Terumo company, Boston Scientific Japan
Profit organization
Nara Medical University Clinical Research Center
840 Shijocho, Kashihara, 643-8521 Nara
0744-29-8836
kasa@naramed-u.ac.jp
NO
湘南鎌倉総合病院 (神奈川県)、関西ろうさい病院 (兵庫県)、奈良県立医科大学病院 (奈良県)、土浦協同病院 (茨城県)、聖マリアンナ医科大学病院 (神奈川県)、久留米学病院外科 (福岡県)、新百合ヶ丘総合病院 (神奈川県)、東京医科歯科大学病院 (東京都)、九州医療センター (福岡県)、旭川医科大学病院 (北海道)、市立函館病院 (北海道)、長崎大学病院 (長崎県)、大阪市立大学病院 (大阪府)、埼玉県立循環器・呼吸器病センター (埼玉県)、鳥取大学病院 (鳥取県)、福岡和白病院 (福岡県)、和歌山県立医科大学病院 (和歌山県)、名古屋大学病院 (愛知県)、東京都済生会中央病院 (東京都)、九州大学病院 (福岡県)、松山赤十字病院 (愛媛県)、住友病院 (大阪府)、慈恵医科大学病院 (東京都)、京都大学病院 (京都府)、水戸済生会総合病院 (茨城県)、大津赤十字病院 (滋賀県、熊本大学病院 (熊本県)、奈良県西和医療センター (奈良県)、岸和田徳洲会病院 (大阪府)、Hospital Marie Lannelongue (フランス、パリ)
2019 | Year | 02 | Month | 01 | Day |
Unpublished
142
The data that support the findings of this study are available from the corresponding author upon reasonable request.
No longer recruiting
2018 | Year | 10 | Month | 01 | Day |
2019 | Year | 04 | Month | 19 | Day |
2019 | Year | 05 | Month | 01 | Day |
2023 | Year | 09 | Month | 30 | Day |
2019 | Year | 01 | Month | 09 | Day |
2023 | Year | 07 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038758
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