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Completed

NCT Number: NCT03863652

Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention via snuffbox approach

Procedure

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.

Primary outcomes

  1. Hemostasis duration (minute)

    Time frame: 1 year

    Hemostasis is obtained by compressive bandage with 3 modified gauzes using cohesive elastic bandage (Peha-Haft®, HARTMANN Inc, SC, USA).

Secondary outcomes

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

    Time frame: 1 year

  2. Success rate of PCI via snuffbox approach (%)

    Time frame: 1 year

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

  3. Puncture site complication after hemostasis

    Time frame: 1 year

    Evaluation of puncture-site bleeding complication using EASY criteria

  4. Snuffbox cannulation time (second)

    Time frame: 1 year

    Time from local anesthesia to sheath cannulation

  5. Success rate of snuffbox approach (%)

    Time frame: 1 year

    Successful introduction of sheath

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

  • The Catholic University of Korea
  • Wakayama Medical University

Registry information

Official study title

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

Acronym: HEMOBOX

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2019
Registry last updated
Apr 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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