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| Name | Class |
|---|---|
| Severance Hospital | OTHER |
| Merit Medical Systems, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous coronary intervention using a 7-Fr thin-walled sheath via the distal radial approach | patients with coronary artery disease who planned to perform PCI using 7-Fr thin-walled sheath via the distal radial approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention via the distal radial approach | Procedure | Percutaneous coronary intervention using a 7-Fr thin walled sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the distal radial approach |
| Measure | Description | Time Frame |
|---|---|---|
| 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]) | Through procedure completion, up to 1month |
| Success rate of PCI | Success rate of PCI using 7-Fr sheath via the distal radial approach (%) | Through procedure completion, up to 1month |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis duration | Hemostasis duration using 7-Fr thin-walled sheath via the distal radial approach (minute) | Through procedure completion, up to 24 hours |
| Patency of proximal radial artery after hemostasis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through procedure completion |
Inclusion Criteria:
Exclusion Criteria:
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patients with coronary artery disease who planned to perform PCI using a 7-Fr thin-walled sheath will be recruited
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| Name | Affiliation | Role |
|---|---|---|
| Yongcheol Kim, MD | Yongin Severance Hopistal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongin Severance Hospital | Yongin | Gyeonggi-do | 16995 | South Korea | ||
| Yongin Severance Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40374669 | Derived | Roh JW, Lee OH, Heo SJ, Kim Y, Im E, Cho DK. Feasibility of percutaneous coronary intervention using a 7-French thin-walled sheath via the distal radial access. Sci Rep. 2025 May 15;15(1):16961. doi: 10.1038/s41598-025-01149-1. |
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No planned
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Patency of proximal radial artery using 7-Fr thin-walled sheath via the distal radial approach by ultrasonography after hemostasis (%)
| 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: up to 1month |
| Yongin |
| South Korea |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |