Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

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

Sponsors

Lead Sponsor: Chonnam National University Hospital

Collaborator: Wakayama Medical University
The Catholic University of Korea

Source Chonnam National University Hospital
Brief Summary

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.

Overall Status Completed
Start Date 2019-03-04
Completion Date 2020-02-28
Primary Completion Date 2020-01-19
Study Type Observational
Primary Outcome
Measure Time Frame
Hemostasis duration (minute) 1 year
Secondary Outcome
Measure Time Frame
Correlation between activated clotting time (ACT) and hemostasis duration 1 year
Success rate of PCI via snuffbox approach (%) 1 year
Puncture site complication after hemostasis 1 year
Snuffbox cannulation time (second) 1 year
Success rate of snuffbox approach (%) 1 year
Enrollment 250
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Percutaneous coronary intervention via snuffbox approach

Description: 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.

Arm Group Label: Snuffboxer

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Location
Facility: Chonnam National University Hospital
Location Countries

Korea, Republic of

Verification Date

2020-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chonnam National University Hospital

Investigator Full Name: Myung Ho Jeong

Investigator Title: Professor

Keywords
Has Expanded Access No
Arm Group

Label: Snuffboxer

Description: Patients undergoing percutaneous coronary intervention via snuffbox approach

Acronym HEMOBOX
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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