ANGIE: Anatomical sNuffbox for Coronary anGiography and IntervEntions

• Sponsor: University Hospital of Patras (Other)
• Overall Status: Completed
• CT.gov ID: NCT03986151
• Collaborator: (none)
• Enrollment: 1,042
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.4
• Patients Per Site Per Month: 51.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Vascular Access Complication	Procedure: Coronary angiography +/- percutaneous coronary intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1042 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Anatomical sNuffbox for Coronary anGiography and IntervEntions
• Actual Study Start Date: Jun 11, 2019
• Actual Primary Completion Date: Feb 20, 2021
• Actual Study Completion Date: Feb 20, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Rate of right radial artery occlusion [≥30 days after CAG or PCI]

Secondary Outcome Measures

1. Rate of successful insertion of the sheath [Immediately post-procedurally]

2. Duration of sheath insertion procedure [Immediately post-procedurally]

3. Rate of successful completion of coronary angiography [Immediately post-procedurally]

4. Rate of successful completion of percutaneous coronary intervention [Immediately post-procedurally]

5. Total Contrast volume [Immediately post-procedurally]

6. Total Fluoroscopy time [Immediately post-procedurally]

7. Total Radiation Dose [Immediately post-procedurally]

8. Total Procedure Time [Immediately post-procedurally]

9. Time required for hemostasis [1-6 hours]

10. Postprocedural Hematoma (modified EASY class) [3 hours]

11. Rate of distal radial artery occlusion [≥30 days after CAG or PCI]

12. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Patras	Patras	Achaia	Greece	26504

Sponsors and Collaborators

• University Hospital of Patras

Investigators

• Principal Investigator: Grigorios Tsigkas, MD, Phd, University Hospital of Patras

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Grigorios Tsigkas, Cardiology consultant, University Hospital of Patras
• ClinicalTrials.gov Identifier: NCT03986151
• Other Study ID Numbers: 11994/6-5-2019
• First Posted: Jun 14, 2019
• Last Update Posted: Mar 12, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Grigorios Tsigkas, Cardiology consultant, University Hospital of Patras: coronary angiography; radial access; distal radial access; anatomical snuffbox; radial artery occlusion
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Mar 12, 2021