Anatomical sNuffbox for Coronary anGiography and IntervEntions

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Vascular Access Complication
• Interventions: Procedure: Coronary angiography +/- percutaneous coronary intervention

• Registration Number: NCT03986151
• Lead Sponsor: University Hospital of Patras

Brief Summary

This randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention.

Detailed Description

Transradial approach has become the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). The current ESC/EACTS guidelines of myocardial revascularization support using radial approach (RA) rather than femoral approach (FA) if the operators are experts for RA. Recently, an alternative transradial access has been suggested at the anatomical snuffbox, with potential additional benefits including a reduction in radial artery occlusion rate (which allows reintervention through the same access site and potential use as a graft), a decrease in other local vascular complications, shorter hemostasis duration, patients' intra and post procedural comfort and shorter recovery time. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Therefore, the aim of the study is to compare the two approaches concerning the patency of the radial artery ≥30 days after the intervention with Doppler in a randomized way. Due to the anastomosis of the distal radial artery with the superficial palmar arch, even in case of total radial artery occlusion within the anatomical snuffbox, the antegrade blood flow may be preserved and, therefore, decreased incidents of radial artery occlusion are expected in the right distal radial artery approach group. The mean diameter of radial artery at the anatomical snuffbox is 2.4 mm, whereas the mean diameter of the radial artery at the forearm is 2.7 mm, and this could potentially contribute to shorter hemostasis duration.

Study Timeline

• Study Start: 2019-06-11
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-14
• Primary Completion: 2021-02-20
• Study Completion: 2021-02-20
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1042

Inclusion Criteria

• Indication for coronary angiography
• Informed consent

Exclusion Criteria

• Non palpable right radial artery
• Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion)
• Prior CABG
• STEMI
• Hemodynamic instability
• Anatomical restrictions (fistula, etc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal radial access	Coronary angiography +/- percutaneous coronary intervention	-
Conventional radial access	Coronary angiography +/- percutaneous coronary intervention	-

Primary Outcome Measures

Name	Time	Method
Rate of right radial artery occlusion	≥30 days after CAG or PCI

Secondary Outcome Measures

Name	Time	Method
Total Procedure Time	Immediately post-procedurally
Rate of successful insertion of the sheath	Immediately post-procedurally
Duration of sheath insertion procedure	Immediately post-procedurally
Rate of successful completion of percutaneous coronary intervention	Immediately post-procedurally
Pain associated with the procedure: Pain scale 0-10	1 hour	Pain scale 0-10. A visual anlog pain scale 0-10 will be shown to the patient post-precedurally. 0=no pain, 10=worst pain. Patient will be asked to report the severity of the pain associated with the procedure.
Rate of successful completion of coronary angiography	Immediately post-procedurally
Total Fluoroscopy time	Immediately post-procedurally
Rate of distal radial artery occlusion	≥30 days after CAG or PCI
Total Contrast volume	Immediately post-procedurally
Postprocedural Hematoma (modified EASY class)	3 hours
Total Radiation Dose	Immediately post-procedurally
Time required for hemostasis	1-6 hours

Trial Locations

Locations (1)

University Hospital of Patras; 🇬🇷 Patras, Achaia, Greece