ACTRN12615000759594
Recruiting
Phase 2
Effect of angioplasty and stenting versus aggressive medical treatment on mortality and stroke in patients with symptomatic intracranial artery stenosis: a randomized controlled trial and a preference cohort
Fuzhou General Hospital of Nanjing Command, PLA and clinical medical college of Fujian medical university0 sites198 target enrollmentJuly 21, 2015
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fuzhou General Hospital of Nanjing Command, PLA and clinical medical college of Fujian medical university
- Enrollment
- 198
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients aged from 18 to 70 years.
- •2\. Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a stenosis from 70% to 99% in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
- •3\. A length less than or equal to 15mm of a stenosis in the target vessel and a vessel size greater than or equal to 2mm.
- •4\. Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
- •5\. CT or MRI scans show no massive cerebral infarction (beyond half of the MCA territory), intracranial hemorrhage, epidural or sub\-dural hemorrhage, and intracranial brain tumor.
- •6\. Patients who understand the purpose of the study and have provided informed consent.
Exclusion Criteria
- •1\. Not able to receive general anesthesia.
- •2\. Not able to receive angiographic assessment.
- •3\. A stenosis \>50% in an extracranial carotid or vertebral artery on the ipsilateral side.
- •4\. Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.
- •5\. A high risk (leading to a stroke or death) to deliver the stent to the lesion.
- •6\. A previous stent or angioplasty in the target lesion.
- •7\. Progressive neurological signs within 24 hours before enrolment
- •8\. Any haemorrhagic infarct within 14 days before enrolment
- •9\. The presence of a cardiac source of embolus
- •10\. Thrombolytic therapy within 24 hours before enrollment
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
Remote ischemic postconditioning in Acute myocardial infarctioAcute myocardial infarction.Acute transmural myocardial infarction of anterior wall, Acute transmural myocardial infarction of inferior wall, Acute transmural myocardial infarction of other sitesI21.0, I21IRCT2014101416229N4Cardiovascular Research Center of Tabriz University of Medical Sciences82
Completed
Not Applicable
Does angioplasty offer benefit over best medical treatment and supervised exercise training in mild to moderate intermittent claudication (MIMIC) patients?ISRCTN37194085Imperial College London (UK)340
Unknown
Not Applicable
Stenting With or Without Coating Compared With Angioplasty in Non-benestent DiseaseCoronary Artery DiseaseNCT00192881Rigshospitalet, Denmark
Completed
Not Applicable
Effect of percutaneous transluminal angioplasty on endothelial function in patients with peripheral arterial diseasePeripheral arterial diseaseJPRN-UMIN000008762Department of Cardiovascular Medicine, Juntendo University School of Medicine60
Recruiting
Not Applicable
Clinical study regarding angioplasty and intraarterial-tPA for intravenous-tPA resistant patients with hyperacute ischemic strokeHyperacute cerebral major vessel occlusionJPRN-UMIN000002809Graduate School of Medicine, Gifu University60