Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557135
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Brachial Versus Femoral Access for Carotid Artery Stenting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Brachial vErsus Femoral Access for carotId Artery sTenting a Multicenter Randomized Clinical Trial BEFIT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEFIT
Brief Summary:
Study purpose
A multicenter prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access
Eligible participants will be randomly assigned 11 to the brachial artery group or the femoral artery group
Primary endpoint surgical success rate
Secondary endpoints
1 Operation time time from first arterial puncture to last angiography
2 Serious adverse events SAE within 90 days
3 Access puncture complications
A multicenter prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access
Eligible participants will be randomly assigned 11 to the brachial artery group or the femoral artery group
Primary endpoint surgical success rate
Secondary endpoints
1 Operation time time from first arterial puncture to last angiography
2 Serious adverse events SAE within 90 days
3 Access puncture complications
Detailed Description:
With the improvement of treatment concepts and the continuous innovation of interventional devicesinterventional technologies neurointervention has become the preferred treatment method for many cerebrovascular diseases Among them the femoral artery is the most commonly used access because the femoral artery is superficial easy to touch and the relatively large vessel diameter allows most neurointerventional surgeries to proceed smoothly However the femoral artery access also has the disadvantages of long bed rest time exposure to private parts and prolonged hospitalization
Thanks to the great success of radial artery access in cardiac intervention radial artery access is increasingly being used in neurointervention However due to the thin radial artery there is a significantly increased risk of complications radial artery spasm radial artery occlusion during large-cavity nerve intervention and the operation time is significantly prolonged Therefore the overall proportion of neurointerventional treatment via radial artery access in clinical practice is less than 12
As the superior vascular trunk of the radial artery the brachial artery has a larger diameter and is theoretically more suitable to replace the radial artery for large-bore intervention Anatomically the brachial artery is superficial and easy to touch in the antecubital fossa and there are no important vessels and nerves in front of the blood vessel and the posterior is the distal humeral platform which is easy for brachial artery puncture and postoperative compression hemostasis Studies have shown that thrombectomy for cerebral artery occlusion and carotid artery stent placement can be safely performed through the brachial artery However current studies are based on single-center small sample studies and there is still a lack of large-sample randomized controlled trials to verify the safety and effectiveness of neurointervention via the brachial artery
This study intends to conduct a multicenter prospective and randomized study to compare the clinical results of carotid artery stent placement via the brachial and femoral artery access
Thanks to the great success of radial artery access in cardiac intervention radial artery access is increasingly being used in neurointervention However due to the thin radial artery there is a significantly increased risk of complications radial artery spasm radial artery occlusion during large-cavity nerve intervention and the operation time is significantly prolonged Therefore the overall proportion of neurointerventional treatment via radial artery access in clinical practice is less than 12
As the superior vascular trunk of the radial artery the brachial artery has a larger diameter and is theoretically more suitable to replace the radial artery for large-bore intervention Anatomically the brachial artery is superficial and easy to touch in the antecubital fossa and there are no important vessels and nerves in front of the blood vessel and the posterior is the distal humeral platform which is easy for brachial artery puncture and postoperative compression hemostasis Studies have shown that thrombectomy for cerebral artery occlusion and carotid artery stent placement can be safely performed through the brachial artery However current studies are based on single-center small sample studies and there is still a lack of large-sample randomized controlled trials to verify the safety and effectiveness of neurointervention via the brachial artery
This study intends to conduct a multicenter prospective and randomized study to compare the clinical results of carotid artery stent placement via the brachial and femoral artery access
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None