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

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

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease, Distal Radial Artery, Complex Intervention

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention via the snuffbox approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, ≥ 20 years of age, who were diagnosed with ischemic heart disease requiring percutaneous coronary intervention (PCI) Patients who are palpable distal radial artery The decision to participate voluntarily in this study and the written consent of the patient Patients who planned to perform PCI using a 7-Fr thin wall sheath Exclusion Criteria: Patients who are not palpable distal radial artery Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study Pregnancy Patients who are not appropriate for this study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Percutaneous coronary intervention using a 7-Fr thin wall sheath via the snuffbox approach<br>patients with coronary artery disease who planned to perform PCI using 7-Fr thin wall sheath via the snuffbox approach | Procedure: Percutaneous coronary intervention via the snuffbox approach<br>* Percutaneous coronary intervention using a 7-Fr thin wall sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the snuffbox approach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access site complication during hospitalization and within 1-month follow-up | bleeding(defined by BARC criteria), hematoma (hand hematoma[<5cm, 5-10cm,>10cm[ and forearm hematoma), numbness, AV fistula, Pseudoaneurysm, and artery occlusion (conventional and distal radial artery) by ultrasonography | Through procedure completion, up to 1month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of PCI | Success rate of PCI using 7-Fr sheath via the snuffbox approach (%) | Through procedure completion, up to 1month | 
| Hemostasis duration | Hemostasis duration using 7-Fr sheath via the snuffbox approach (minute) | Through procedure completion, up to 24 hours | 
| Patency of proximal radial artery after hemostasis | Patency of proximal radial artery using 7-Fr sheath via the snuffbox 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 sheath via the snuffbox approach by ultrasonography after 1-month (%) | Time Frame: up to 1month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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distal radial artery, coronary artery disease, percutaneous coronary intervention