Multi-institutional domestic clinical test of TCD-15152
- Conditions
- Subjects with a target carotid stenosis (more than 50% stenosis if symptomatic or more than 80% stenosis if asymptomatic) located CCA or ICA.
- Registration Number
- JPRN-UMIN000023562
- Lead Sponsor
- TERUMO CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method (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