Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585917
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Study Comparing the Efficacy and Safety of 6F and 7F Thin-Walled Sheaths Via Distal Radial Artery Access for Coronary Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a multicenter randomized controlled prospective non-inferiority open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery dTRA access for coronary intervention PCI are non-inferior to the use of a 6F thin-walled sheath The study population includes adult patients who are candidates for coronary intervention The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure
Detailed Description:
This study is a multicenter randomized controlled prospective non-inferiority open-label clinical trial designed to compare the efficacy and safety of using 7F thin-walled sheaths versus 6F thin-walled sheaths for coronary intervention PCI via distal radial artery access dTRA The study will enroll adult patients with coronary artery disease who are scheduled to undergo PCI
Participants will be randomized into two groups the experimental group which will receive PCI using a 7F sheath and the control group which will receive PCI using a 6F sheath The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure assessed by ultrasound Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events during follow-up cannulation success rate PCI success rate and the rate of radial artery occlusion at 30 days post-procedure among others
The study aims to determine whether the 7F sheath is non-inferior to the 6F sheath in terms of safety and efficacy for PCI through dTRA The study will be conducted at multiple centers in China with a planned enrollment of 574 participants and it will span from Sep 2024 to January 2026 All procedures will adhere to the highest standards of clinical practice and patient data will be managed with strict confidentiality
Participants will be randomized into two groups the experimental group which will receive PCI using a 7F sheath and the control group which will receive PCI using a 6F sheath The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure assessed by ultrasound Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events during follow-up cannulation success rate PCI success rate and the rate of radial artery occlusion at 30 days post-procedure among others
The study aims to determine whether the 7F sheath is non-inferior to the 6F sheath in terms of safety and efficacy for PCI through dTRA The study will be conducted at multiple centers in China with a planned enrollment of 574 participants and it will span from Sep 2024 to January 2026 All procedures will adhere to the highest standards of clinical practice and patient data will be managed with strict confidentiality
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