JPRN-UMIN000023562CompletedPhase 3
Multi-institutional domestic clinical test of TCD-15152 - Multi-institutional domestic clinical test of TCD-15152
TERUMO CORPORATIO0 sites140 target enrollmentStarted: August 12, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
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.
Investigators
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