UMIN-CTR Clinical Trial

Basic information
Public title	Multi-institutional domestic clinical test of TCD-15152
Acronym	Multi-institutional domestic clinical test of TCD-15152
Scientific Title	Multi-institutional domestic clinical test of TCD-15152
Scientific Title:Acronym	Multi-institutional domestic clinical test of TCD-15152
Region	Japan

Condition
Condition	Subjects with a target carotid stenosis (more than 50% stenosis if symptomatic or more than 80% stenosis if asymptomatic) located CCA or ICA.
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and effectiveness of the TCD-15152 when used in the treatment of Carotid stenosis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Primary Endpoint Non-incidence of Major adverse event (death, stroke and myocardial infarction within 30 days after procedure, ipsilateral stroke within 1year after procedure)
Key secondary outcomes	(1)Secondary Safety Endpoint 1.Incidence of Adverse Events 2.Incidence of Serious Adverse Events 3.Incidence of Major Adverse Events 4.Incidence of Adverse investigational Device Effect 5.Incidence of stent stenosis 6.Neurological death 7.Incidence of cerebrovascular disorder 7-1.Stroke 7-2.Transient Ischaemic Attack 8.Incidence of cranial neuropathy (2)Secondary Effectiveness 1.Incidence of procedure success. 2.Incidence of technical success: 3.Non-incidence of Target Lesion Revascularization

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)Select an appropriate-sized TCD-15152 system by performing a diagnostic angiogram. (3)Remove the tray with delivery system from the pouch (4)Remove the delivery system from the tray. (5)Attach a syringe filled with sterile heparinized saline solution to the RHV luer and flush the delivery system. (6)Access the target vessel using appropriate-sized guiding sheath or guiding catheter and insert and expand an EPD. (7)If required, pre-dilation with the balloon catheter inside the stent may be done with standard PTA technique. (8)Access the treatment site using the appropriate accessory equipment and insert an EPD usable as a guidewire (9)Expand and deploy TCD-15152 stent. Expansion and deployment are completed by maintaining inner shaft position (holding handle) while retracting the outer sheath. (10)If the TCD-15152 stent positioning is not satisfactory across the target lesion, the inplant may be recaptured and repositioned up to 50% of its deployment from the catheter delivery system. (11)Withdraw the delivery system carefully. (12)If required, post-dilation with the balloon catheter inside the stent may be done with standard PTA technique. (13)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	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion Criteria (1)Subject whose age is >=20 years; (2)Subject fulfills study requirements, and the subject or his/her Legally Authorized Representative (3)Subject commits to return to the investigational site for the follow-up evaluations. (4)Females of childbearing potential must have documented negative pregnancy test within 7 days of Index Procedure and are to remain on an acceptable birth control method at least until the day of the clinical trial. (5)Patient has a target lesion located at the CCA or ICA. Angiographic Inclusion Criteria (6)Patient has a single de novo or restenotic (post CEA) target lesion or severe tandem lesions close enough that can be covered by a single TCD-15152 stent. (7)Patients having a vessel with reference diameters between 3.5 mm and 9.0 mm at the target lesion. (8)Patient is either: a. Symptomatic with carotid stenosis: >=50% as determined by angiography using NASCET methodology, or PSV >=130cm/sec as deterined by ultrasonography. b,Asymptomatic with carotid stenosis : >=50% as determined by angiography using NASCET methodology, or PSV >=230cm/sec as deterined by ultrasonography. (9)Embolic protection device can be used safely.
Key exclusion criteria	1.Life expectancy of less than one year. 2.mRS >3 or another neurological deficit not due to stroke that may confound the neurological patient assessments. 3.Anticipated or potential sources of emboli that are not adequately treated with anticoagulants. 4.Platelet count <100,000/uL. 5.Sensitivity to heparin or previous incidence of HIT type II. 6.Active bleeding diathesis or hypercoagulable state or not able to receive blood transfusions. 7.Contraindication to standard of care study medications, including antiplatelet therapy. 8.Chronic renal insufficiency or has a history of severe hepatic impairment, malignant hypertension. 9.Documented contrast allergy, or other condition, that prohibits imaging. 10.Hypersensitivity to metal. 11.Currently enrolled in another study. 12.High degree of cognitive dysfunction and not capable of IC. 13.Previously placed stent or graft in the ipsilateral carotid artery. 14.Atheroma that may complicate the safe CAS. 15.Severe lesion calcification or vascular tortuosity that may preclude the safe introduction of the sheath, guiding catheter, EPD, or stent. 16.State that may complicate the safe CAS. 17.Intracranial pathology that, in the opinion of the investigator, makes the patient inappropriate for study participation. 18.Intracranial hemorrhage within the last 90 days. 19.Experiencing an evolving, acute, or recent disabling stroke in the last 30 days. 20.Any major surgical procedure that may affect evaluation within 30 days of the index procedure. 21.Carotid stenosis contralateral to the target lesion treated within 30 days following the index procedure. 22.Acute MI within 72 hours prior to index procedure. 23.Mobile filling defect felt or thrombus in target lesion. 24.Occlusion or presence of string sign of the target lesion. 25.Carotid stenosis located distal to target stenosis that is more severe than target stenosis. 26.>50% stenosis of the CCA proximal to the target lesion. 27.Mobile plaque or thrombus in the aortic arch.
Target sample size	138

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Nobuyuki Sakai
Organization	Kobe City Medical Center General Hospital
Division name	Cranial nerve surgery
Zip code
Address	1-1 ,Minamicho ,Minatojima ,Kobe-shi, Hyogo, Japan
TEL	078-302-4321
Email	n.sakai@siren.ocn.ne.jp

Public contact
1st name of contact person	1st name Middle name Last name Atsuko Suzuki
Organization	TERUMO CORPORATION
Division name	Clinical Development Department
Zip code
Address	49F Tokyo Operacitytower, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL	0367428248
Homepage URL
Email	atsuko_suzuki@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	2016 Year 08 Month 12 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	140
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	2016 Year 06 Month 03 Day
Date of IRB	2016 Year 07 Month 11 Day
Anticipated trial start date	2016 Year 08 Month 16 Day
Last follow-up date	2018 Year 12 Month 07 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 01 Month 31 Day
Date analysis concluded	2019 Year 04 Month 12 Day

Other
Other related information

Management information
Registered date	2016 Year 08 Month 09 Day
Last modified on	2019 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027077