Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

Bleeding Clinical Trial

— HEMOBOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03863652
• Other study ID #: HEMOBOX
• Status: Completed
• Start date: March 4, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2020
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 28, 2020
• Est. primary completion date: January 19, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artery Injury
• Bleeding
• Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (3)

Lead Sponsor	Collaborator
Chonnam National University Hospital	The Catholic University of Korea, Wakayama Medical University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

Archbold RA, Robinson NM, Schilling RJ. Radial artery access for coronary angiography and percutaneous coronary intervention. BMJ. 2004 Aug 21;329(7463):443-6. Review. — View Citation

Berezhnoi K, Kokov L, Vanyukov A, Kim Y. Complete revascularization via left snuffbox approach in a nonagenarian patient with acute myocardial infarction. Cardiol J. 2018;25(4):530-531. doi: 10.5603/CJ.2018.0083. — View Citation

Bertrand OF, Larose E, Rodés-Cabau J, Gleeton O, Taillon I, Roy L, Poirier P, Costerousse O, Larochellière RD. Incidence, predictors, and clinical impact of bleeding after transradial coronary stenting and maximal antiplatelet therapy. Am Heart J. 2009 Ja — View Citation

Bertrand OF, Rao SV, Pancholy S, Jolly SS, Rodés-Cabau J, Larose E, Costerousse O, Hamon M, Mann T. Transradial approach for coronary angiography and interventions: results of the first international transradial practice survey. JACC Cardiovasc Interv. 20 — View Citation

Doyle BJ, Rihal CS, Gastineau DA, Holmes DR Jr. Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice. J Am Coll Cardiol. 2009 Jun 2;53(22):2019-27. doi: 10.1016/j.jacc.2008.1 — View Citation

Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimský P; ESC Scientific Document Gr — View Citation

Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079. — View Citation

Kim Y, Ahn Y, Kim I, Lee DH, Kim MC, Sim DS, Hong YJ, Kim JH, Jeong MH. Feasibility of Coronary Angiography and Percutaneous Coronary Intervention via Left Snuffbox Approach. Korean Circ J. 2018 Dec;48(12):1120-1130. doi: 10.4070/kcj.2018.0181. Epub 2018 — View Citation

Kim Y, Ahn Y, Kim MC, Sim DS, Hong YJ, Kim JH, Jeong MH. Gender differences in the distal radial artery diameter for the snuffbox approach. Cardiol J. 2018;25(5):639-641. doi: 10.5603/CJ.2018.0128. — View Citation

Kim Y, Jeong MH, Berezhnoi K, Lee SY, Kim MC, Sim DS, Hong YJ, Kim JH, Ahn Y. Recannulation of Distal Radial Artery for Staged Procedure After Successful Primary Percutaneous Coronary Intervention. J Invasive Cardiol. 2018 Oct;30(10):E105-E106. — View Citation

Kim Y, Jeong MH, Kim I, Kim MC, Sim DS, Hong YJ, Kim JH, Ahn Y. Intravascular Ultrasound-Guided Percutaneous Coronary Intervention with Drug-eluting Stent for Unprotected Left Main Disease via Left Snuffbox Approach. Korean Circ J. 2018 Jun;48(6):532-533. — View Citation

Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group . 201 — View Citation

Valsecchi O, Vassileva A, Cereda AF, Canova P, Satogami K, Fiocca L, Guagliumi G. Early Clinical Experience With Right and Left Distal Transradial Access in the Anatomical Snuffbox in 52 Consecutive Patients. J Invasive Cardiol. 2018 Jun;30(6):218-223. Ep — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis duration (minute)	Hemostasis is obtained by compressive bandage with 3 modified gauzes using cohesive elastic bandage (Peha-Haft®, HARTMANN Inc, SC, USA).	1 year
Secondary	Correlation between activated clotting time (ACT) and hemostasis duration		1 year
Secondary	Success rate of PCI via snuffbox approach (%)	The frequency of success rate of percutaneous coronary intervention via snuffbox approach	1 year
Secondary	Puncture site complication after hemostasis	Evaluation of puncture-site bleeding complication using EASY criteria	1 year
Secondary	Snuffbox cannulation time (second)	Time from local anesthesia to sheath cannulation	1 year
Secondary	Success rate of snuffbox approach (%)	Successful introduction of sheath	1 year