Anatomical sNuffbox for Coronary anGiography and IntervEntions (ANGIE)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Vascular Access Complication
• Intervention / Treatment: Procedure: Coronary angiography +/- 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 Type: Interventional
• Enrollment (Actual): 1042
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Patras, Achaia, Greece, 26504
      • University Hospital of Patras

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional radial access	Procedure: Coronary angiography +/- percutaneous coronary intervention; Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)
EXPERIMENTAL: Distal radial access	Procedure: Coronary angiography +/- percutaneous coronary intervention; Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of right radial artery occlusion	≥30 days after CAG or PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Fluoroscopy 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 coronary angiography		Immediately post-procedurally
Rate of successful completion of percutaneous coronary intervention		Immediately post-procedurally
Total Contrast volume		Immediately post-procedurally
Total Radiation Dose		Immediately post-procedurally
Total Procedure Time		Immediately post-procedurally
Time required for hemostasis		1-6 hours
Postprocedural Hematoma (modified EASY class)		3 hours
Rate of distal radial artery occlusion		≥30 days after CAG or PCI
Pain associated with the procedure: Pain scale 0-10	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.	1 hour

Collaborators and Investigators

• Sponsor: University Hospital of Patras

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2019
• Primary Completion (ACTUAL): February 20, 2021
• Study Completion (ACTUAL): February 20, 2021

Study Registration Dates

• First Submitted: June 11, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: coronary angiography; radial artery occlusion; radial access; distal radial access; anatomical snuffbox
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 11994/6-5-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No