Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05416853
Status:
UNKNOWN
Last Update Posted:
2022-09-01
First Post:
2022-06-06
Brief Title:
Radial Versus Femoral Access For Carotid Artery Stenting
Sponsor:
The First Affiliated Hospital of University of Science and Technology of China
Organization:
The First Affiliated Hospital of University of Science and Technology of China
Study Overview
Official Title:
Radial Versus Femoral Access For Carotid Artery Stenting In Patients With Carotid-Artery Stenosis a Prospective Randomized Multicenter Noninferiority Trial
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RACE-CAS
Brief Summary:
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 Seldingers 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 points1 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-operation6 mRS score score changes post-operation 7 X-ray exposure Safety outcomes 1Occurrence of all adverse events 2 AEs related to operation and device 3 Incidence of adverse event of special interest
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 points1 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-operation6 mRS score score changes post-operation 7 X-ray exposure Safety outcomes 1Occurrence of all adverse events 2 AEs related to operation and device 3 Incidence of adverse event of special interest
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None