Anatomical sNuffbox for Coronary anGiography and IntervEntions

NCT ID: NCT03986151

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1042 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2021-02-20

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.

Conditions

Coronary Artery Disease; Vascular Access Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional radial access

Group Type: ACTIVE_COMPARATOR

Coronary angiography +/- percutaneous coronary intervention

Intervention Type: PROCEDURE

Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)

Distal radial access

Group Type: EXPERIMENTAL

Coronary angiography +/- percutaneous coronary intervention

Intervention Type: PROCEDURE

Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)

Interventions

Coronary angiography +/- percutaneous coronary intervention

Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Patras

OTHER

Sponsor Role: lead

Responsible Party

Grigorios Tsigkas

Cardiology consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Grigorios Tsigkas, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Patras

Locations

University Hospital of Patras

Pátrai, Achaia, Greece

Countries

Greece

Other Identifiers

11994/6-5-2019

Identifier Type: -

Identifier Source: org_study_id