View clinical trials related to Cerebral Revascularization.
Filter by:Background: For moderate to severe carotid artery atherosclerotic stenosis, in the past decades, carotid artery stenting (CAS) has been an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. The transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for CAS. The radial artery is an ideal puncture site for cerebrovascular intervention. Studies have shown that nerve intervention through radial artery approach can complete most cerebrovascular intervention procedures, including cerebral angiography, carotid artery stent implantation, vertebral artery stent implantation, intracranial artery stent implantation, mechanical thrombectomy, aspiration, intra-arterial thrombolysis and so on. However, the current studies are based on single center small sample studies, and there has been still a lack of large sample randomized controlled experiments to verify the safety and effectiveness of CAS in transradial artery (TRA) . Objective: To evaluate the efficacy and safety of CAS via TRA in patients with carotid artery stenosis through a multicenter, prospective and randomized study. Study design: This study is a randomized, open label, multicenter, parallel controlled trial. A non-inferiority test is performed to compare the primary end point between the experimental group and the control group. The experimental group will undergo carotid stent implantation via radial artery approach, while the control group will use femoral artery approach. Study population: Adult patients with symptomatic carotid-artery stenosis ≥50% or asymptomatic stenosis ≥70%. Study outcomes: Primary end points: The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure Secondary end points:1. The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure. 2. The incidence of death within 48 hours / 30 days post-procedure. 3. The incidence of new-onset stroke within 48 hours / 30 days post-procedure. 4. The incidence of myocardial infarction within 48 hours / 30 days post-procedure. 5. The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure. Other end points: 1. Successful rate of DSA. 2. Successful rate of endovascular treatment. 3. Degree of patient-reported comfort. 4. Operation time 5. NIHSS score changes post-operation.6. mRS score score changes post-operation. 7. X-ray exposure. Safety outcomes: 1.Occurrence of all adverse events. 2. AEs related to operation and device. 3. Incidence of adverse event of special interest.
Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood flow monitoring and blood pressure, and combining patient demographics and preoperative risk factors to establish an applicable individual blood pressure controlling model. By comparing with routine antihypertensive strategies through prospective randomized controlled trials , to provide the best perioperative blood pressure control standards and strategies for each patient ,thus better ensuring the safety and efficacy of CEA .