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Feasibility of PCI Using a 7-Fr Thin-Wall Sheath Via the DRA — SEVEN-BOX  

Coronary Artery Disease Clinical Trial

Official title:
Feasibility of Percutaneous Coronary Intervention Using a 7-Fr Thin Wall Sheath Via the Snuffbox Approach: a Prospective Observational Study (SEVEN-BOX)

Clinical Trial Summary

To evaluate the safety and effectiveness of percutaneous coronary intervention using a 7-French(Fr) thin wall sheath via the snuffbox approach

Clinical Trial Description

Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial artery access (DRA), also known as the snuffbox approach, have shown several advantages owing to fewer complications, such as radial artery occlusion, pseudoaneurysms, and arteriovenous(AV) fistulas, and short hemostasis duration than the proximal radial access (PRA). However, despite the potential advantages of the DRA, there are still many cardiologists who prefer the femoral approach for complex PCI including left main disease, bifurcation lesions, heavily calcified lesions, which need a strong backup and using several devices. The radial artery and the distal radial artery have a smaller diameter than the femoral artery, and interventional cardiologists are usually performed using the 6-Fr sheath. The previously developed 7-Fr sheath has a higher risk of vascular occlusion when use in a radial artery due to larger diameter compared to radial artery in 30% to 60% of patients. However, with the recent development of various technologies, the outer diameter of the sheath is gradually becoming thinner and recently a 7-Fr slender sheath which does not differ significantly from the outer diameter of the 6-Fr sheath used in the previously PRA demonstrated that feasibility and safety for radial artery intervention. Despite the feasibility and potential benefits of the DRA and 7-Fr thin wall sheath for radial artery, there is a lack of data regarding the safety and efficacy of a 7-Fr thin-wall sheath during the DRA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05006027
Study type Observational [Patient Registry]
Source Yonsei University
Contact
Status Active, not recruiting
Phase
Start date August 16, 2021
Completion date October 15, 2024
View Details
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