UMIN-CTR Clinical Trial

Public title

Multi-institutional clinical test of TCD-14139

Acronym

Multi-institutional clinical test of TCD-14139

Scientific Title

Multi-institutional clinical test of TCD-14139

Scientific Title:Acronym

Multi-institutional clinical test of TCD-14139

Region

Japan

Condition

Subjects with a target unruptured intracranial aneurysm located along the internal carotid artery,anterior cerebral artery,middle cerebral artery,vertebral artery, and basilar artery have no applicability to previous treatment.

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety and effectiveness of the TCD-14139 when used in the
treatment of intracranial aneurysms.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Primary Safety Endpoint;
Proportion of subjects who experience severe event related safty at 12 months
post procedure.

Primary Effectiveness:
Proportion of treatment success within 12 months post procedure.

Key secondary outcomes

Secondary Safety Endpoint
Incidence of Adverse Events.
Incidence of Adverse Device Effect.
Incidence of Adverse Device Effect and procedure related Adverse Events.
Incidence of Serious Adverse Events.
Incidence of Serious Adverse Device Effec.
Incidence of Adverse Device Effect and procedure related Serious Adverse Events.
Incidence of significant adverse events.(thromboembolic event,hemorrhagic event)
Physical finding.
Incidence or worsening of neurologic signs/symptoms, as measured by NIHSS.

Secondary Effectiveness
Incidence of treatment success.
In the evaluation of degree of obstruction.
Incidence of successful delivery of the TCD-14139 System implant.
Incidence of migration of the TCD-14139 System implant.
Unplanned alternative treatment on the target IA within 12 months.
Study Success Criteria
Overall study success will be met if both the primary efficacy and primary safety endpoints are met.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

(1)Gain vascular access according to standard angiographic practice.(2)Place appropriate size guidecatheter according to standard practice.(3)Coaxially navigate a microcatheter (TCD-H) over a guidewire to the aneurysm neck or target location.(4)Select an appropriate-sized TCD-14139 system.(5)Advance the delivery wire to transfer the TCD-14139 system from within the introducer into the microcatheter.(6)Position the TCD-14139 system for deployment by aligning the TCD-14139 system implant distal radiopaque end markers past the aneurysm neck.(7)Carefully inspect the deployed TCD-14139 implant under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked. If the implant is not fully apposed or is kinked, consider utilizing a suitable microguidewire and/or occlusion balloon catheter to fully open the implant.
(8)After completing the procedure, withdraw and discard all applicable accessory devices.

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 whose age is >=20 and 80 >=years;
(2)Subject fulfills study requirements, and the subject or his/her Legally Authorized Representative
provides a signed informed consent form;
(3)Negative pregnancy test in a female subject.
(4)Subject commits to return to the investigational site for the 30-day, 6-month, and 12-month follow-up evaluations.
(5)Subject has a single target aneurysm located in the following zones:
- Petrous through superior hypophyseal segments of the ICA
- Communicating segment of the ICA through A1 or M1 segment
- Posterior Circulation
(6)(7)AND fit any of the following criteria:
Subject whose target aneurysm has a neck >=4mm or no discernible neck AND a size(maximum fundus diameter) >=10 mm OR subject has a fusiform aneurysm of any size requiring treatment OR Subject is a poor candidate for open surgical treatment because of prior surgical
procedure, comorbidities or location limiting conventional surgical options
OR Subject for whom exiting endovascular options (coiling, stent-assisted coiling) would be ineffective because the aneurysm is predisposed to recurrence due to having any of the
following characteristics:
a. Aneurysm has a maximum fundus diameter less than 10mm but >=7mm
b. Aneurysm has any of the following morphologies:
i. segmental parent artery dysplasia
ii. aneurysm neck involving > 180 degrees of parent artery circumference
iii. complex lobulations limiting stent/coiling as a treatment option
iv. neck >=4mm or dome/neck ratio>2
(8)The parent artery diameter must be 2.5-5.0mm distal/proximal to the target intracranialaneurysm;

Key exclusion criteria

(1)(2)SAH in the last 60 days or intracranial hemorrhage in the last 30 days(3)Intracranial mass or currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region.(4)Symptomatic extracranial or intracranial stenosis of the parent artery(>50%) proximal to the target aneurysm;(5)Irreversible bleeding disorder.(6)Current alcohol or substance abuse.(7)uncontrolled severe hypertension
>180 mm Hg or>115 mmHg,(8)cre 3.0mg/dL;(9)Hypersensitivity to metal, such as nickel-titanium and metal jewelry.
(10)(11)Subject with contraindications or known allergies to anticoagulants or antiplatelets (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);Subject with documented contrast allergy, or other condition, that prohibits imaging.(12)Evidence of active infection at the time of treatment;(13)Presence of any of the unequivocal cardiac sources of embolism;
(14)Intracranial stenting procedure associated with the target aneurysm;
(15)Cerebral diagnostic angiogram that demonstrates an aneurysm that is not appropriate for endovascular treatment;(16)Subject has extracranial stenosis greater than 50% in the carotid artery of the targetaneurysm.(17)Subject has intracranial stenosis greater than 50% in the treated vessel(18)Subject has a mycotic or dissecting aneurysm.(19)Subject has a bifurcation.(20)Subject has a posterior circulation aneurysm.(21)Subjects aneurysm has significant branch exiting from dome of aneurysm.(22)Subject is harboring more than one aneurysm with both aneurysms requiring treatment at the same time.(23)Subject has an AVM in the area of the target aneurysm.

Target sample size

27

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi yamamoto

Organization

TERUMO CORPORATION

Division name

Clinical Development Department

Zip code

Address

1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan

TEL

0465-81-4104

Email

satoshi_yamamoto@terumo.co.jp

Name of contact person

1st name
Middle name
Last name	satoshi yamamoto

Organization

TERUMO CORPORATION

Division name

Clinical Development Department

Zip code

Address

1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan

TEL

0465-81-4104

Homepage URL

Email

satoshi_yamamoto@terumo.co.jp

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

2014

Year

07

Month

28

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

2014

Year

07

Month

18

Day

Date of IRB

2014

Year

07

Month

23

Day

Anticipated trial start date

2014

Year

08

Month

05

Day

Last follow-up date

2016

Year

02

Month

09

Day

Date of closure to data entry

Date trial data considered complete

2017

Year

03

Month

31

Day

Date analysis concluded

Other related information

Registered date

2014

Year

07

Month

28

Day

Last modified on

2020

Year

08

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017001