An observational study in Coronary Artery Disease, Distal Radial Artery and Complex Intervention, sponsored by Yonsei University. Completed at 2 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Yonsei University · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 100 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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patients with coronary artery disease who planned to perform PCI using a 7-Fr thin-walled sheath will be recruited
Exclusion Criteria:
patients with coronary artery disease who planned to perform PCI using 7-Fr thin-walled sheath via the distal radial approach
Procedure: Percutaneous coronary intervention via the distal radial approach
Percutaneous coronary intervention using a 7-Fr thin walled sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the distal radial approach
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
If intravascular imaging modalities (OCT/IVUS) are seen during intervention, check for conventional radial radial artery complications through OCT/IVUS
If intravascular imaging modalities (OCT/IVUS) are seen during intervention, check for conventional radial radial artery complications through OCT/IVUS
Time frame: Through procedure completion
Plan to share: No — No planned
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Yonsei University