Subjects with a target carotid stenosis (more than 50% stenosis if symptomatic or more than 80% stenosis if asymptomatic) located CCA or ICA.
Conditions
Interventions
(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 fro
Sponsors
TERUMO CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint Non-incidence of Major adverse event (death, stroke and myocardial infarction within 30 days after procedure, ipsilateral stroke within 1year after procedure) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactAtsuko Suzuki
TERUMO CORPORATION Clinical Development Department
Outcome results
None listed