Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

Completed

• Conditions: Bleeding; Artery Injury
• Interventions: Procedure: Percutaneous coronary intervention via snuffbox approach

• Registration Number: NCT03863652
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study Start: 2019-03-04
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-05
• Primary Completion: 2020-01-19
• Study Completion: 2020-02-28
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-12
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Snuffboxer	Percutaneous coronary intervention via snuffbox approach	Patients undergoing percutaneous coronary intervention via snuffbox approach

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of