HEMOBOX: Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

Sponsor
Chonnam National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03863652
Collaborator
Wakayama Medical University (Other), The Catholic University of Korea (Other)
250
1
11.9
21.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Percutaneous coronary intervention via snuffbox approach

Study Design

Study Type:
Observational
Actual Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach: a Prospective Observational Study
Actual Study Start Date :
Mar 4, 2019
Actual Primary Completion Date :
Jan 19, 2020
Actual Study Completion Date :
Feb 28, 2020

Arms and Interventions

Arm Intervention/Treatment
Snuffboxer

Patients undergoing percutaneous coronary intervention via snuffbox approach

Procedure: Percutaneous coronary intervention via snuffbox approach
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Correlation between activated clotting time (ACT) and hemostasis duration [1 year]

  2. Success rate of PCI via snuffbox approach (%) [1 year]

    The frequency of success rate of percutaneous coronary intervention via snuffbox approach

  3. Puncture site complication after hemostasis [1 year]

    Evaluation of puncture-site bleeding complication using EASY criteria

  4. Snuffbox cannulation time (second) [1 year]

    Time from local anesthesia to sheath cannulation

  5. Success rate of snuffbox approach (%) [1 year]

    Successful introduction of sheath

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chonnam National University Hospital Gwangju Korea, Republic of 61469

Sponsors and Collaborators

  • Chonnam National University Hospital
  • Wakayama Medical University
  • The Catholic University of Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Myung Ho Jeong, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT03863652
Other Study ID Numbers:
  • HEMOBOX
First Posted:
Mar 5, 2019
Last Update Posted:
Apr 14, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Myung Ho Jeong, Professor, Chonnam National University Hospital

Study Results

No Results Posted as of Apr 14, 2020