Anatomical sNuffbox for Coronary anGiography and IntervEntions

Coronary Artery Disease Clinical Trial

— ANGIE  

Official title:

Anatomical sNuffbox for Coronary anGiography and IntervEntions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03986151
• Other study ID #: 11994/6-5-2019
• Status: Completed
• Phase: N/A
• Start date: June 11, 2019
• Est. completion date: February 20, 2021

Study information

• Verified date: March 2021
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1042
• Est. completion date: February 20, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Vascular Access Complication

Intervention

Procedure:
• Coronary angiography +/- percutaneous coronary intervention
Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patras	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of right radial artery occlusion		=30 days after CAG or PCI
Secondary	Rate of successful insertion of the sheath		Immediately post-procedurally
Secondary	Duration of sheath insertion procedure		Immediately post-procedurally
Secondary	Rate of successful completion of coronary angiography		Immediately post-procedurally
Secondary	Rate of successful completion of percutaneous coronary intervention		Immediately post-procedurally
Secondary	Total Contrast volume		Immediately post-procedurally
Secondary	Total Fluoroscopy time		Immediately post-procedurally
Secondary	Total Radiation Dose		Immediately post-procedurally
Secondary	Total Procedure Time		Immediately post-procedurally
Secondary	Time required for hemostasis		1-6 hours
Secondary	Postprocedural Hematoma (modified EASY class)		3 hours
Secondary	Rate of distal radial artery occlusion		=30 days after CAG or PCI
Secondary	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