Anatomical sNuffbox for Coronary anGiography and IntervEntions (ANGIE)
Primary Purpose
Coronary Artery Disease, Vascular Access Complication
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Coronary angiography +/- percutaneous coronary intervention
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring coronary angiography, radial access, distal radial access, anatomical snuffbox, radial artery occlusion
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)
Sites / Locations
- University Hospital of Patras
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional radial access
Distal radial access
Arm Description
Outcomes
Primary Outcome Measures
Rate of right radial artery occlusion
Secondary Outcome Measures
Rate of successful insertion of the sheath
Duration of sheath insertion procedure
Rate of successful completion of coronary angiography
Rate of successful completion of percutaneous coronary intervention
Total Contrast volume
Total Fluoroscopy time
Total Radiation Dose
Total Procedure Time
Time required for hemostasis
Postprocedural Hematoma (modified EASY class)
Rate of distal radial artery occlusion
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.
Full Information
NCT ID
NCT03986151
First Posted
June 11, 2019
Last Updated
March 9, 2021
Sponsor
University Hospital of Patras
1. Study Identification
Unique Protocol Identification Number
NCT03986151
Brief Title
Anatomical sNuffbox for Coronary anGiography and IntervEntions
Acronym
ANGIE
Official Title
Anatomical sNuffbox for Coronary anGiography and IntervEntions
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
February 20, 2021 (Actual)
Study Completion Date
February 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Patras
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Vascular Access Complication
Keywords
coronary angiography, radial access, distal radial access, anatomical snuffbox, radial artery occlusion
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1042 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional radial access
Arm Type
Active Comparator
Arm Title
Distal radial access
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Coronary angiography +/- percutaneous coronary intervention
Intervention Description
Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)
Primary Outcome Measure Information:
Title
Rate of right radial artery occlusion
Time Frame
≥30 days after CAG or PCI
Secondary Outcome Measure Information:
Title
Rate of successful insertion of the sheath
Time Frame
Immediately post-procedurally
Title
Duration of sheath insertion procedure
Time Frame
Immediately post-procedurally
Title
Rate of successful completion of coronary angiography
Time Frame
Immediately post-procedurally
Title
Rate of successful completion of percutaneous coronary intervention
Time Frame
Immediately post-procedurally
Title
Total Contrast volume
Time Frame
Immediately post-procedurally
Title
Total Fluoroscopy time
Time Frame
Immediately post-procedurally
Title
Total Radiation Dose
Time Frame
Immediately post-procedurally
Title
Total Procedure Time
Time Frame
Immediately post-procedurally
Title
Time required for hemostasis
Time Frame
1-6 hours
Title
Postprocedural Hematoma (modified EASY class)
Time Frame
3 hours
Title
Rate of distal radial artery occlusion
Time Frame
≥30 days after CAG or PCI
Title
Pain associated with the procedure: Pain scale 0-10
Description
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.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grigorios Tsigkas, MD, Phd
Organizational Affiliation
University Hospital of Patras
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Patras
City
Patras
State/Province
Achaia
ZIP/Postal Code
26504
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Anatomical sNuffbox for Coronary anGiography and IntervEntions
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