UMIN-CTR Clinical Trial

Basic information
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
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

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	TERUMO CORPORATION
Institute
Department

Funding Source
Organization	TERUMO CORPORATION
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2014 Year 07 Month 28 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	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
Other related information

Management information
Registered date	2014 Year 07 Month 28 Day
Last modified on	2020 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017001