Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

Study Overview
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Brief Summary
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Transradial approach has been preferred for coronary angiography (CAG) and percutaneous coronary intervention (PCI) due to several advantages, including decreased associated vascular complication, patients' convenience, and early ambulation compared with transfemoral approach. With these advantages, current guidelines support that radial access is recommended for CAG and PCI in acute myocardial infarction (AMI) patients with and without ST-elevation if performed by an experienced radial operator. Recently, Kiemeneij introduced a distal radial artery approach, called the snuffbox approach, and several studies have been published. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Moreover, optimal hemostasis duration for PCI via snuffbox approach has not been investigated, even though shorter hemostasis duration would be expected compared with the conventional radial approach as diameter of snuffbox radial artery was significantly smaller than conventional radial artery. In addition, there are few data regarding the feasibility of PCI via snuffbox approach. Therefore, the aim of the study is to evaluate the optimal hemostasis duration for PCI via snuffbox approach.

Official Title
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Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach: a Prospective Observational Study

Conditions
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Artery Injury, Bleeding

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years old requiring PCI Patients who are palpable distal radial arter The decision to participate voluntarily in this study and the written consent of the patient 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. Patients who are not appropriate for this study

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Snuffboxer<br>Patients undergoing percutaneous coronary intervention via snuffbox approach | Procedure: Percutaneous coronary intervention via snuffbox approach<br>* After local anesthesia on left or right anatomical snuffbox with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by an insertion of the 5Fr. or 6Fr radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan). The selection of puncture device is at physician discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis duration (minute) | Hemostasis is obtained by compressive bandage with 3 modified gauzes using cohesive elastic bandage (Peha-Haft®, HARTMANN Inc, SC, USA). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between activated clotting time (ACT) and hemostasis duration |  | 1 year | 
| Success rate of PCI via snuffbox approach (%) | The frequency of success rate of percutaneous coronary intervention via snuffbox approach | 1 year | 
| Puncture site complication after hemostasis | Evaluation of puncture-site bleeding complication using EASY criteria | 1 year | 
| Snuffbox cannulation time (second) | Time from local anesthesia to sheath cannulation | 1 year | 
| Success rate of snuffbox approach (%) | Successful introduction of sheath | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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snuffbox approach, distal radial approach, hemostasis