UMIN-CTR Clinical Trial

Public title

Safety and Efficacy of Cerebral Aneurysm Embolization Devices

-Observational Study-

Acronym

Safety and Efficacy of Cerebral Aneurysm Embolization Devices

-Observational Study-

Scientific Title

Safety and Efficacy of Cerebral Aneurysm Embolization Devices

-Observational Study-

Scientific Title:Acronym

Safety and Efficacy of Cerebral Aneurysm Embolization Devices

-Observational Study-

Region

Japan

Condition

cerebral aneurysm
Cerebral arteriovenous malformation
Cerebral arteriovenous fistula

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To understand the actual status of use of
detachable coils, which are classified as
electrical detachable coils including i-ED
coil, in Japan in the field of cranial nerve IVR

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1) Aneurysm cases
Reopening rate at 12 months of treatment
2) Arteriovenous malformation and arteriovenous fistula
Reoperation rate at 12 months of treatment

Key secondary outcomes

1) In addition to the evaluation of the following items at each time point, the transition and amount of change up to 12 months after treatment will be evaluated.
NIHSS, modified Rankin Scale (mRS), re-treatment or not, Raymond Scale (only for aneurysm cases), loss of venous perfusion (only for arteriovenous fistula cases)
2) Success rate of the procedure
3) Percentage of cases with >50% reduction in size (volume) of arteriovenous malformation immediately after treatment

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

18

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Male and female patients between the ages of 18 and 80
2) Patients undergoing endovascular treatment with coils for intracranial arterial lesions (aneurysm, arteriovenous malformation, arteriovenous fistula)
3) Patients in whom more than 50% of coils used for endovascular treatment were i-ED coils
4) Patients who have given written consent to participate in this study from the research subjects themselves

Key exclusion criteria

1) Patients with significant stenosis (>50%) in the parent extracranial or intracranial artery proximal to the target aneurysm
2) Patients with target aneurysm in the anterior circulation of the proximal portion of the subxiphoid artery
3) Patients who need to leave the neck to maintain blood flow in the bifurcation or branch in the treatment of a target aneurysm
4) Patients undergoing coiling or stenting of non-target lesions within 30 days prior to treatment of the target lesion
5) Patients with multiple aneurysms and treatment of other aneurysms within 30 days of treatment of the target aneurysm under investigation
6) Patients undergoing flow diverter implantation for treatment of target aneurysm to be studied
7) Patients with a Hunt and Hess score of 3 or higher or a modified Rankin Scale (mRS) score of 4 or higher
8) Patients with contraindications to CT or MRI
9) Patients with contraindications to angiography

Target sample size

130

Name of lead principal investigator

1st name	Kenji
Middle name
Last name	Sugiu

Organization

Okayama University Hospital

Division name

Department of Neurological Surgery

Zip code

700-8558

Address

2-5-1 Shikatacho, Kita-ku, Okayama

TEL

086-223-7151

Email

ksugiu@md.okayama-u.ac.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Arai

Organization

Nouvelle Place Inc.

Division name

-

Zip code

1050001

Address

3-8-21 Toranomon, Minato-ku, Tokyo

TEL

03-6680-2525

Homepage URL

Email

i-ED@n-place.co.jp

Institute

Kaneka Corporation

Institute

Department

Personal name

Organization

Kaneka Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Corporation Rikeikai Yamauchi Clinic Ethics Review Board

Address

1-15-19 Jiyugaoka, Meguro-ku, Tokyo

Tel

03-6777-1490

Email

c-irb_ug@neues.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

07

Month

26

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000055238

Publication of results

Unpublished

URL related to results and publications

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000055238

Number of participants that the trial has enrolled

118

Results

The number and percentage of patients with aneurysms who had recanalization at 12 months of treatment were 0 (0%) out of 76 patients.
The number and percentage of patients with arteriovenous malformations and arteriovenous fistula who underwent retreatment by 12 months of treatment were
0 (0%) out of 37 cases.
In this study, both aneurysms and cerebral arteriovenous malformations/cerebral arteriovenous fistulas satisfied the expected effective probability specified when designing the number of cases.

Results date posted

2024

Year

09

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Age(year):
Mean(SD):61.8(13.0), Median:65.5, Min,Max:32,79

Gernder
Male(%):42(35.6), Female(%):76(64.4)

Intra-capilart artery lession
Aneurysm(%):81(68.6%), Arteriovenous malformation(%):4(3.4), Arteriovenous fistula(%):33(28.0)

Participant flow

Enrollment:118,Safety analysis subjects:118,FAS:118

Adverse events

Adverse events:3 cases (Cerebral infarction:2, Cerebral hemorrhage:1)
1. Cerebral infarction (Outcome:Recovery,Severity:mild,Causality:Probable,Treatment:none,SAE:yes)
2. Cerebral infarction (Outcome:Recovery,Severity:mild,Causality:Definine,Treatment:Administration of antiplatelet agennts,SAE:yes)
3. Cerebral hemorrhage (Outcome:Recovery but sequela,Severity:moderate,Causality:Probable,Treatment:none,SAE:yes)

Outcome measures

Primary endpoint

1.Number and percentage of cases with recanalization(Raymond Scale 1 or 2 to 3) at 12 months postoperatively
-Aneurysm(n):76
-Recanalization(n):0
-Incidence(%):0.0
2.Number and percentage of cases that were re-treated by 12 months postoperatively
-Arteriovenous malformation / Arteriovenous fistula (n):37
-Retreatment(n):0
-Incidence(%):0.0

Secondary endpoint(n, Mean, SD, Min, Median, Max)

1.NIHSS
<Total>
-Baseline: 56, 0.4 ,1.7 ,0 ,0 ,12
-POM1: 49, 0.0, 0.0, 0, 0, 0
-POM6: 36, 0.2, 0.7, 0, 0, 4
-POM12: 44, 0.1, 0.3, 0, 0, 2
-dPOM1: 49, -0.2, 0.7, -3, 0, 0
-dPOM6: 35, -0.5, 1.6, -8, 0, 2
-dPOM12: 43, -0.4, 1.6, -10, 0, 1
< Aneurysm >
-Baseline: 42, 0.3, 1.9, 0, 0, 12
-POM1: 36, 0.0, 0.0, 0, 0, 0
-POM6: 27, 0.2, 0.8, 0, 0, 4
-POM12: 36, 0.1, 0.4, 0, 0, 2
-dPOM1: 36, -0.1, 0.2, -1, 0, 0
-dPOM6: 26, -0.3, 1.6, -8, 0, 2
-dPOM12: 35, -0.3, 1.7, -10, 0, 1
< Arteriovenous malformation >
-Baseline: 2, 0.0, 0.0, 0, 0, 0
-POM1: 2, 0.0, 0.0, 0, 0, 0
-POM6: 1, 0.0, -, 0, 0, 0
-POM12: 1, 0.0, -, 0, 0, 0
-dPOM1: 2, 0.0, 0.0, 0, 0, 0
-dPOM6: 1, 0.0, -, 0, 0, 0
-dPOM12: 1, 0.0, -, 0, 0, 0
< Arteriovenous fistula >
-Baseline: 12, 0.9, 1.2, 0, 0, 3
-POM1: 11, 0.0, 0.0, 0, 0, 0
-POM6: 8, 0.0, 0.0, 0, 0, 0
-POM12: 7, 0.0, 0.0, 0, 0, 0
-dPOM1: 11, -0.8, 1.2, -3, 0, 0
-dPOM6: 8, -1.1, 1.2, -3, -1, 0
-dPOM12: 7, -0.9, 1.1, -2, 0, 0

2.mRS
<Total>
-Baseline: 114, 0.3, 0.7, 0, 0, 3
-POM1: 98, 0.3, 0.8, 0, 0, 4
-POM6: 99, 0.2, 0.6, 0, 0, 4
-POM12: 98, 0.2, 0.7, 0, 0, 4
-dPOM1: 97, 0.0, 0.8, -2, 0, 4
-dPOM6: 98, -0.1, 0.7, -3, 0, 4
-dPOM12: 96, -0.1, 0.7, -3, 0, 4
< Aneurysm >
-Baseline: 80, 0.1, 0.5, 0, 0, 3
-POM1: 67, 0.2, 0.8, 0, 0, 4
-POM6: 73, 0.1, 0.5, 0, 0, 3
-POM12: 72, 0.1, 0.4, 0, 0, 3
-dPOM1: 66, 0.1, 0.7, -2, 0, 4
-dPOM6: 72, 0.0, 0.4, -3, 0, 1
-dPOM12: 71, 0.0, 0.4, -3, 0, 1
< Arteriovenous malformation >
-Baseline: 3, 0.0, 0.0, 0, 0, 0
-POM1: 2, 0.0, 0.0, 0, 0, 0
-POM6: 2, 0.0, 0.0, 0, 0, 0
-POM12: 2, 0.0, 0.0, 0, 0, 0
-dPOM1: 2, 0.0, 0.0, 0, 0, 0
-dPOM6: 2, 0.0, 0.0, 0, 0, 0
-dPOM12: 2, 0.0, 0.0, 0, 0, 0
< Arteriovenous fistula >
-Baseline: 31, 0.8, 0.9, 0, 1, 3
-POM1: 29, 0.4, 0.9, 0, 0, 4
-POM6: 24, 0.4, 0.9, 0, 0, 4
-POM12: 24, 0.4, 0.9, 0, 0, 4
-dPOM1: 29, -0.2, 1.0, -2, 0, 4
-dPOM6: 24, -0.3, 1.1, -2, 0, 4
-dPOM12: 23, -0.3, 1.1, -2, 0, 4

3.Number of cases re-treated by 12 months postoperatively
-Total(n):118, Aneurysm:81, Arteriovenous malformation:4, Arteriovenous fistula:33
-Retreatment(n):0, Aneurysm:0, Arteriovenous malformation:0, Arteriovenous fistula:0
-Incidence(%):0.0, Aneurysm:0.0, Arteriovenous malformation:0.0, Arteriovenous fistula:0.0

4.Number of cases of Raymond Scale Class I
-During treatment: Total:81, Number of cases:63, Percentage (%):77.8
-At 6 months postoperatively: Total:55, Number of cases:47, Percentage (%):85.5
-At 12 months postoperatively: Total:80, Number of cases:67, Percentage (%):83.8

5.Number of cases in which venous blockade had resolved by 12 months postoperatively
- Arteriovenous fistula: Total:27, Number of cases:27, Percentage (%):100.0

6.Success or failure of the procedure (presence or absence of treatment/procedure-related defects)
*Cases that meet all three of the following criteria at the time of treatment are considered successful, and all other cases are considered failures.
1.Embolization is "Cured/Complete occlusion" or "subtotal occlusion
2.No adverse events related to the procedure
3.No failure related to the treatment procedure
-Total:118, Success:116, Failure:2, Success (%):98.3, Failure (%):1.7
-Aneurysm:81, Success:79, Failure:2, Success (%):97.5, Failure (%):2.5
- Arteriovenous malformation:4, Success:4, Failure:0, Success (%):100.0, Failure (%):0.0
- Arteriovenous fistula:33, Success:33, Failure:0, Success (%):100.0, Failure (%):0.0

7.Number of cases with >50% reduction in arteriovenous malformation size (volume) immediately after treatment
　(Cases in which embolization is selected as "Cured/Complete occlusion" or "subtotal occlusion" at 12 months postoperatively)
- Arteriovenous malformation:Total:2, Number of cases:2, Percentage (%):100.0

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2022

Year

07

Month

07

Day

Date of IRB

2022

Year

07

Month

22

Day

Anticipated trial start date

2022

Year

07

Month

22

Day

Last follow-up date

2023

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

2023

Year

04

Month

10

Day

Date analysis concluded

2023

Year

04

Month

20

Day

Other related information

This study will allow us to understand the actual use of detachable coils, which are classified as electrical detachable type including i-ED coils, in Japan in the field of cranial nerve IVR, and may contribute to future medical advances in the treatment of this area.

Registered date

2022

Year

07

Month

26

Day

Last modified on

2024

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055238