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Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03863652
Acronym
HEMOBOX
Enrollment
250
Registered
2019-03-05
Start date
2019-03-04
Completion date
2020-02-28
Last updated
2020-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artery Injury, Bleeding

Keywords

snuffbox approach, distal radial approach, hemostasis

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.

Interventions

PROCEDUREPercutaneous 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.

Sponsors

Wakayama Medical University
CollaboratorOTHER
The Catholic University of Korea
CollaboratorOTHER
Chonnam National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Correlation between activated clotting time (ACT) and hemostasis duration1 year
Success rate of PCI via snuffbox approach (%)1 yearThe frequency of success rate of percutaneous coronary intervention via snuffbox approach
Puncture site complication after hemostasis1 yearEvaluation of puncture-site bleeding complication using EASY criteria
Snuffbox cannulation time (second)1 yearTime from local anesthesia to sheath cannulation
Success rate of snuffbox approach (%)1 yearSuccessful introduction of sheath

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026