UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031042 |
|---|---|
| Receipt number | R000035425 |
| Scientific Title | The efficacy and safety of trans-catheter embolization for inferior mesenteric artery and lumbar artery to prevent persistent type 2 endoleak prior to endovascular abdominal aortic aneurysm repair (EVAR) with Endurant2 stent-graft:multicenter prospective study |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2025/02/04 21:38:15 |
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Basic information
Public title
The efficacy and safety of trans-catheter embolization for inferior mesenteric artery and lumbar artery to prevent persistent type 2 endoleak prior to endovascular abdominal aortic aneurysm repair (EVAR) with Endurant2 stent-graft:multicenter prospective study
Acronym
TAE for IMA and LA prior to EVAR(Endurant)study
Scientific Title
The efficacy and safety of trans-catheter embolization for inferior mesenteric artery and lumbar artery to prevent persistent type 2 endoleak prior to endovascular abdominal aortic aneurysm repair (EVAR) with Endurant2 stent-graft:multicenter prospective study
Scientific Title:Acronym
TAE for IMA and LA prior to EVAR(Endurant)study
Region
| Japan |
Condition
Condition
Abdominal aortic aneurysm
Classification by specialty
| Vascular surgery | Radiology | Cardiovascular surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy and safety of trans-catheter embolization for inferior mesenteric artery and lumbar artery to prevent persistent type 2 endoleak(EL2) prior to endovascular abdominal aortic aneurysm repair (EVAR) with Endurant2 stent-graft: multicenter prospective study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
The incidence of EL2 after EVAR in 6 months
Key secondary outcomes
The incidence of EL2 after EVAR in 1 year
Technical success rate of IMA/LA embolization
Safety of IMA/LA embolization
Aneurysm diameter after EVAR within 30days, 6 month and 1 year
Aneurysm related death after EVAR within 30days, 6 month and 1 year
Re-intervention rate for EL2 after EVAR within 30days, 6 month and 1 year
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Trans-catheter embolization for inferior mesenteric artery and lumbar artery with metalic coil prior to EVAR with Endurant2 stent-graft
Interventions/Control_2
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
The formation of abdominal aortic aneurysm is within the instruction for use (IFU) of Endurant2 stent-graft system.
The patients who is out of indication for open surgical repair, or refuse open surgical repair.
The patients who have sufficient renal function (eGFR above 30)
The patent branch vessels originated from aneurysm is at least above one confirmed with preoperative CT image.
ECOG performance status is 0 or 1.
Key exclusion criteria
Rupture case
The severe stenosis or occlusion of superior mesenteric artery
The bilateral occlusion of internal iliac artery
Uncontrollable of heart failure, angina pectoris, and arrhythmia despite of treatment
Concomitant with active cancer
Sever drug allergy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kobe University Hospital
Division name
Department of Radiology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6104
masato03310402@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Masato |
Organization
Kobe University Hospital
Division name
Department of Radiology
Zip code
650-0017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6104
Homepage URL
masato03310402@yahoo.co.jp
Sponsor or person
Institute
Department of Radiology, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
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
Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku,
Tel
078-382-6629
kainyu@med.kobe-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000035425
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S2211568424000792
Number of participants that the trial has enrolled
100
Results
Pre-emptive embolization succeeded in 80.9% (321/397) of aortic side branches, including 86.3% of inferior mesenteric, 80.3% of lumbar, and 55.6% of other arteries, with no severe adverse events. Late type II endoleak incidence at 6 months was 8.9% (8/90; 95% CI: 3.9-16.8%). Aneurysm sac shrinkage >5 mm was observed in 41.1% (37/90) at 6 months and 55.3% (47/85) at 12 months. No re-intervention was required for type II endoleak, and no aneurysm-related deaths occurred.
Results date posted
| 2025 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
100 patients with abdominal aortic aneurysm were enrolled from nine hospitals between 2018 and 2021. There were 85 men and 15 women, with a mean age of 79.6+-6.0 (standard deviation) years (range: 65-97 years).
Participant flow
All 100 eligible patients underwent EVAR and completed follow-up at 1 month.
At 6 months, 90 patients (90/100; 90%) completed follow-up, with one dying of acute myocardial infarction, five not visiting the outpatient clinic, and four not undergoing contrast-enhanced CT (three due to worsening renal function not related to EVAR, and one who refused examination).
At 12 months, 85 patients (85/100; 85%) completed follow-up, with one dying of pneumonia, one dying of cerebral infarction, and three not visiting the outpatient clinic.
Adverse events
No severe adverse events, including colonic ischemia or spinal cord ischemia, were reported as a result of pre-emptive embolization.
Outcome measures
The incidence of EL2 after EVAR in 1 year: 8.9% (8/90; 95% CI: 3.9-16.8)
Technical success rate of IMA/LA embolization: Coil embolization was successful in 80.9% (321/397) of patent aortic side branches, including 86.3% of the inferior mesenteric arteries, 80.3% of lumbar arteries, and 55.6% of other branches
Safety of IMA/LA embolization: No adverse events
Aneurysm diameter after EVAR within 30 days, 6 months, and 1 year: The median aneurysm sac change at 6 and 12 months was -3.0 mm (Q1, Q3: -6.9, -3.0; range: -18.3 to 4.0 mm) and -5.0 mm (Q1, Q3: -10.0, -4.0; range: -25.0 to 8.0 mm), respectively.
Aneurysm-related death after EVAR within 30 days, 6 months, and 1 year: No aneurysm-related death
Re-intervention rate for EL2 after EVAR within 30 days, 6 months, and 1 year: No re-intervention for EL2
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 04 | 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
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035425
