UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035502 |
|---|---|
| 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 | 2025/01/13 16:22:07 |
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Basic information
Public title
Efficacy of preemptive inferior mesenteric artery embolization during endovascular aortic aneurysm repair
Acronym
Clarify IMA
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
Scientific Title:Acronym
Clarify IMA
Region
| Japan | Europe |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Cardiology | Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate an efficacy of preemptive embolization of IMA during EVAR for reduction of persistent type II endoleak and following sac enlargement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of aneurysm sac change in both arms at 12M after EVAR
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Preemptive embolization of IMA during EVAR
Interventions/Control_2
Control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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)
Key exclusion criteria
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
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Ichihashi |
Organization
Nara Medical University
Division name
Radiology
Zip code
6348521
Address
840 Shijocho, Kashihara, Nara
TEL
+81744298900
ichihash@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Ichihashi |
Organization
Nara Medical University
Division name
Radiology
Zip code
6348521
Address
840 Shijocho, Kashihara, Nara
TEL
+81744298900
Homepage URL
ichihash@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
W.L.Gore & Associates, Terumo company, Boston Scientific Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Clinical Research Center
Address
840 Shijocho, Kashihara, 643-8521 Nara
Tel
0744-29-8836
kasa@naramed-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
a
Publication of results
Unpublished
Result
URL related to results and publications
a
Number of participants that the trial has enrolled
142
Results
IMA embolization was successful in 63 of 70 patients without any adverse event. At 12 months, there was no significant difference in aneurysm sac volume change between the embolization group (-3.90%) and the control group (-3.56%; P=0.89). Furthermore, no significant differences were observed in sac diameter change, rates of type II endoleak, freedom from reintervention, and overall survival at any follow-up point.
Results date posted
| 2025 | Year | 01 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the participants was 76 years old, and 117 among 138 participants (85%) were male. There were no significant differences between the groups at baseline including anatomical parameters.
Participant flow
Between August 2019 and March 2022, a total 608 patients matched the inclusion criteria. Among them, 468 were excluded due to a variety of reasons. Consequently, 140 patients were enrolled in the study, with 70 patients in each group (embolization group and control group). As stated earlier, two patients refused to undergo EVAR after randomization, leaving 138 participants to be analyzed in the study.
Adverse events
There were no adverse events related with IMA embolization. There was no perioperative mortality in either group.
Outcome measures
The primary outcome measure was the percent change in CT-assessed aneurysm sac volume at 12 months post-EVAR. Secondary outcome measures included corresponding values at 6 and 24 months, changes in aneurysm sac diameter at 6, 12, and 24 months, prevalence of type II endoleak post-procedure and at 6, 12, and 24 months, incidence of reintervention, mortality, operation time, fluoroscopy time, and volume of contrast media used during EVAR.
Plan to share IPD
The data that support the findings of this study are available from the corresponding author upon reasonable request.
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038758
