UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051653 |
|---|---|
| Receipt number | R000058942 |
| Scientific Title | Multicenter prospective randomized trial of aneurysm sac side branch embolization during endovascular aneurysm repair |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/04/24 15:36:26 |
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Basic information
Public title
Multicenter prospective randomized trial of aneurysm sac side branch embolization during endovascular aneurysm repair
Acronym
Multicenter study of side branch embolization during EVAR
Scientific Title
Multicenter prospective randomized trial of aneurysm sac side branch embolization during endovascular aneurysm repair
Scientific Title:Acronym
RCT of Side Branch Embolization during EVAR
Region
| Japan |
Condition
Condition
Abdominal Aortic Aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of prophylactic embolization of aneurysmal side branches during endovascular aneurysm repair
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One-year aneurysm sac shrinkage after EVAR
Key secondary outcomes
Two- / Three-year sac shrinkage after EVAR, Incidence of type II endoleaks, Overall survival, Freedom from aneurysm-related death, Freedom from re-intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Control group: Regular EVAR + IMA embolization for patients with patent inferior mesenteric artery (IMA)
Interventions/Control_2
Aneurysmal sac side branch (ASSB) prophylactic embolization group: Regular EVAR + embolization of the side branches at the aneurysm.
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
Patients 18 years of age or older with spindle-shaped abdominal aortic aneurysm indicated for surgery (maximum short-axis diameter >50 mm or rapid enlargement >5 mm/6 months) and judged to be eligible for standard EVAR at each institution.
Patients who understand the study and give written consent.
Patients must be eligible from the date of study approval to March 31, 2026.
Key exclusion criteria
Patients whose all lumbar arteries at the aneurysm site are occluded.
Subjects with systemic conditions or advanced malignancies that are expected to have a life expectancy of less than 1 year.
Patients with known hereditary diseases such as Marfan syndrome or Ehlers-Danlos syndrome
Infected aortic aneurysm
Isolated iliac artery aneurysm
Patients with isolated iliac artery aneurysm, isolated iliac artery aneurysm, cystic aneurysm, or PAU (penetrating atherosclerotic ulcer).
Patients with severe allergy to iodine contrast media who cannot use contrast media
Patients with renal impairment with preoperative eGFR less than 30 ml/min/1.73 m2 and not on dialysis
Women who are pregnant, possibly pregnant, within 28 days postpartum, or lactating.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Banno |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Vascular and Endovascular Surgery, Department of Surgery
Zip code
466-8550
Address
65 tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-741-2111
hbanno@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yayoi |
| Middle name | |
| Last name | Furuta |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Vascular and Endovascular Surgery, Department of Surgery
Zip code
466-8550
Address
65 tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2224
Homepage URL
yfuruta@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-741-2111
ethics@med.nagoya-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
名古屋大学大学院医学系研究科，日本赤十字社愛知医療センター名古屋第一病院，一宮市立市民病院，トヨタ記念病院，JA愛知厚生連豊田厚生病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058942
