To evaluate the safety and effectiveness of percutaneous coronary intervention using a 7-French(Fr) thin-walled sheath via the distal radial approach
Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial artery access (DRA) 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 thin-walled 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-walled sheath for radial artery, there is a lack of data regarding the safety and efficacy of a 7-Fr thin-walled sheath during the DRA.
Study Type
OBSERVATIONAL
Enrollment
100
Percutaneous coronary intervention using a 7-Fr thin walled sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the distal radial approach
Yongin Severance Hospital
Yongin, Gyeonggi-do, South Korea
Yongin Severance Hospital
Yŏngin, South Korea
Access site complication during hospitalization and within 1-month follow-up
bleeding(defined by BARC criteria), hematoma (using modified EASY\[Early Discharge After Transradial Stenting of Coronary Arteries Study\] classification: A) Grade Ia hematoma was subclassified into 4 grades from the puncture site \[Grade 1, \<2cm; Grade2, 2-5cm; Grade3,\>5cm; and grade 4, hand swelling\], B) Grade Ib, wrist \< 5cm, C) Grade II, wrist \< 10cm, D) Grade III, forearm, E) Grade IV, upper arm), numbness, AV fistula, Pseudoaneurysm, and conventional and distal radial artery occlusion (assessed by manual palpation or ultrasonography\[prefer\])
Time frame: Through procedure completion, up to 1month
Success rate of PCI
Success rate of PCI using 7-Fr sheath via the distal radial approach (%)
Time frame: Through procedure completion, up to 1month
Hemostasis duration
Hemostasis duration using 7-Fr thin-walled sheath via the distal radial approach (minute)
Time frame: Through procedure completion, up to 24 hours
Patency of proximal radial artery after hemostasis
Patency of proximal radial artery using 7-Fr thin-walled sheath via the distal radial approach by ultrasonography after hemostasis (%)
Time frame: Through procedure completion, up to 24 hours
Patency of distal radial artery after 1 month
Patency of distal radial artery using 7-Fr thin-walled sheath via the snuffbox approach by ultrasonography after 1-month (%)
Time frame: Time Frame: up to 1month
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