UMIN-CTR Clinical Trial

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

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

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

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

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)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

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

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

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

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

2016

Year

08

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

08

Month

09

Day

Last modified on

2019

Year

05

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027077