Optimal Hemostasis Duration for Percutaneous Coronary Intervention Via Snuffbox Approach

NCT03863652 | Completed

• 1 other identifier: HEMOBOX
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Artery Injury

Keywords

snuffbox approach; distal radial approach; hemostasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Correlation between activated clotting time (ACT) and hemostasis duration

  1 year

• Success rate of PCI via snuffbox approach (%)

  1 year

• Puncture site complication after hemostasis

  1 year

• Snuffbox cannulation time (second)

  1 year

• Success rate of snuffbox approach (%)

  1 year

Study Arms (1)

Snuffboxer

Patients undergoing percutaneous coronary intervention via snuffbox approach

Procedure: Percutaneous coronary intervention via snuffbox approach

Interventions

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.

Snuffboxer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Wakayama Medical University: collaborator
• The Catholic University of Korea: collaborator

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Related Publications (14)

• Archbold RA, Robinson NM, Schilling RJ. Radial artery access for coronary angiography and percutaneous coronary intervention. BMJ. 2004 Aug 21;329(7463):443-6. doi: 10.1136/bmj.329.7463.443. No abstract available.

  PMID: 15321904 RESULT

• 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.2008.12.073.

  PMID: 19477350 RESULT

• Bertrand OF, Rao SV, Pancholy S, Jolly SS, Rodes-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. 2010 Oct;3(10):1022-31. doi: 10.1016/j.jcin.2010.07.013.

  PMID: 20965460 RESULT

• 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. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

  PMID: 26320110 RESULT

• 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, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

  PMID: 28886621 RESULT

• 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.

  PMID: 28506941 RESULT

• 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. Epub 2018 Mar 15.

  PMID: 29543187 RESULT

• 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 Aug 6.

  PMID: 30088362 RESULT

• 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. doi: 10.4070/kcj.2018.0016. No abstract available.

  PMID: 29856149 RESULT

• 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. No abstract available.

  PMID: 30211930 RESULT

• 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.

  PMID: 30279299 RESULT

• 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.

  PMID: 30394514 RESULT

• Bertrand OF, Larose E, Rodes-Cabau J, Gleeton O, Taillon I, Roy L, Poirier P, Costerousse O, Larochelliere RD. Incidence, predictors, and clinical impact of bleeding after transradial coronary stenting and maximal antiplatelet therapy. Am Heart J. 2009 Jan;157(1):164-9. doi: 10.1016/j.ahj.2008.09.010. Epub 2008 Nov 6.

  PMID: 19081414 RESULT

• Roh JW, Kim Y, Takahata M, Shiono Y, Kim HY, Jeong MH, Akasaka T. Optimal hemostasis duration for percutaneous coronary intervention via the snuffbox approach: A prospective, multi-center, observational study (HEMOBOX). Int J Cardiol. 2021 Sep 1;338:79-82. doi: 10.1016/j.ijcard.2021.06.035. Epub 2021 Jun 24.

  PMID: 34171449 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 5, 2019
• Study Start: March 4, 2019
• Primary Completion: January 19, 2020
• Study Completion: February 28, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)