Clinical trial NCT03863652: Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach
Official title: Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding
Artery Injury
Keywords: snuffbox approach
distal radial approach
hemostasis
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Wakayama Medical University
name: The Catholic University of Korea
First posted: 2019-03-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 250 patients who undergoing PCI via snuffbox approach will be recruited from 3 centers (with potential to expand number of centers) participating in patients with ischemic heart disease (IHD).

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.


Eligibility 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

Primary outcomes:
measure: Hemostasis duration (minute)
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between activated clotting time (ACT) and hemostasis duration
timeFrame: 1 year
measure: Success rate of PCI via snuffbox approach (%)
timeFrame: 1 year
measure: Puncture site complication after hemostasis
timeFrame: 1 year
measure: Snuffbox cannulation time (second)
timeFrame: 1 year
measure: Success rate of snuffbox approach (%)
timeFrame: 1 year
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
Study officials:
References:
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