Those patients who have stenosis of more than 50% of the common carotid artery or internal carotid artery (diagnosed by ultrasonography or angiography), with neurological symptoms (transient cerebral ischemic stroke or cerebral stroke), or who have stenosis of more than 80% of the common carotid artery or internal carotid artery (diagnosed by ultrasonography or angiography) even if there are no neurological symptoms.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Those patients for whom surgical treatment (carotid endarterectomy [CEA]) is difficult, and whose target vessel diameter is between 5 to 9 mm, and who meet either of the following criteria: Having atheromatous stenosis of more than 50% of the common carotid artery or internal carotid artery that had been diagnosed by ultrasonography or angiography, with neurological symptoms (transient cerebral ischemic stroke or cerebral stroke). Having atheromatous stenosis of more than 80% of the common carotid artery or internal carotid artery that had been diagnosed by ultrasonography or angiography, even if there are no neurological symptoms. 2 Those patients who can be administered concomitantly with aspirin and cilostazol from at least 3 days before CAS.
Exclusion criteria
Exclusion criteria: 1Ischemic stroke within previous 48 hr 2Presence of intraluminal thrombus 3Total occlusion of target vessel 4Intracranial aneurysm > 9 mm in diameter 5Need for more than two stents 6History of bleeding disorder 7Percutaneous or surgical intervention planned within next 30 days 8Life expectancy < 1 year 9Ostial lesion of common carotid artery 10Ostial lesion of brachiocephalic artery 11Contraindication of Pletaal 12Contraindication of Aspirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1Cumulative incidence of death, stroke, or myocardial infarction within 30 days after CAS. 2Cumulative incidence of death or ipsilateral stroke between 31 days and 1 year after CAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1Cumulative number of target-vessel revascularization at 1 year after CAS. 2Cumulative number of restenosis at 1 year after CAS. Restenosis is defined as 50% or more stenosis diagnosed by angiography when cerebral infarction is suspected. | — |
Countries
Japan
Contacts
Saitama medical university international medical center Department of Endovascular Neurosurgery