UMIN-CTR Clinical Trial

Public title

Clinical study of Wide-Necked Intracranial Artery Aneurysms using Self-Expanding Retrievable device System

Acronym

TCD-11114 Clinical study

Scientific Title

Clinical study of Wide-Necked Intracranial Artery Aneurysms using Self-Expanding Retrievable device System

Scientific Title:Acronym

TCD-11114 Clinical study

Region

Japan

Condition

Wide-Necked Intracranial Artery Aneurysms

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of the TCD-11114 when used to facilitate endovascular coiling of wide-neck intracranial aneurysms.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Clinical success:The all of the following criteria within 6 months.
1. Successful placement of the TCD-11114;
2. Parent artery patency;
3. Successful the TCD-11114 placement with satisfactory coil mass position;
4. Non occurrence of any major stroke or death within 30 days;
5. Non occurrence of major ipsi-lateral stroke or neurological death within 6months;

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Treatment of Wide-Necked Intracranial Artery Aneurysms using Self-Expanding Retrievable device System

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

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Subject with the following unruptured aneurysm which are made a diagnosis based on an angiography or 3D-CTA and so on within 1 year.
- A maximum diameter >= 5 mm
- wide-neck (neck >= 4 mm or dome to neck ratio < 2)
(2)Subject with aneurysm arises from a parent vessel with a diameter of >= 2.0 mm and <= 4.5 mm by a diagnosis of an angiography or 3D-CTA and so on within 1 year.
(3)Subject with aneurysms are difficult to treat both surgically and endovascularly with clipping or only coiling.
(4)Subject whose age is >= 20 years and < 80 years.
(5)Subject understands the procedure and contents, and then provides signed informed consent form by his/her own free will.
(6)Subject is willing to return to the investigational site for planned follow-up evaluations based on the protocol.

Key exclusion criteria

Exclusion Criteria;
(1)Subject with Subarachnoid hemorrhage (SAH, ruptured cerebral aneurysm).
(2)Subject who has an intracranial mass, abscess, or other agglomeration from an infection.Subject who is currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.
(3)Subject with dementia.
(4) Subject with a history of bleeding diathesis, blood clotting defect, or with International Normalized Ratio (INR) >= 1.5, and or who refuses blood transfusion.
(5) Subject with serum creatinine level > 2.0 mg/dL.
(6)Subject with a life threatening allergy to contrast.
(7)Subject with known allergies to nickel-titanium metal.
(8) Subject with known allergies to aspirin, heparin, ticlopidine.
(9)Subject who is expected to lives less than 6 months.
(10)Subject who is currently participating in another clinical research study for medical devices and/or medicine.
(11) Subject who placed a carotid stent for symptomatic hemodynamic derangement within 12 weeks.
(12)Subject who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as AFIB (atrial fibrillation).
(13)Subject who is in pregnancy or is suspected pregnancy.
(14)Subject who has allergies or tolerance to aspirin and/or ticlopidine at preoperative antiplatelet therapy.
Angiographic Exclusion Criteria;
(15)Subject with a maximum diameter < 5 mm of aneurysm.
(16)Subject with aneurysm arises from a parent vessel with a diameter of < 2.0 mm and > 4.5 mm.
(17)Subject who judged that the target aneurysm is unsuitable for vascular treatment by angiography.
(18)Subject has an arteriovenous malformation (AVM) in the territory of the target aneurysm.
(19)Subject's aneurysm is expected to require more than one stent.

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Nobuyuki Sakai

Organization

Institute of Biomedical Research and Innovation

Division name

NeuroEndovascular Therapy & Neurological Research Group

Zip code

Address

2-2 Minatojima-Mimimimachi Chuo-ku Kobe 650-0047, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Terumo Corporation

Division name

Clinical Development Department

Zip code

Address

TEL

Homepage URL

Email

Institute

Terumo Corporation

Institute

Department

Personal name

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2012

Year

09

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

07

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

09

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

09

Month

25

Day

Last modified on

2014

Year

04

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010162