Distal vs Proximal Radial Approach for Coronary Interventions
Primary Purpose
Coronary Disease, Vascular Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronary angiography using distal radial artery
coronary angiography using proximal radial artery
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Disease focused on measuring coronary disease, snuff box, radial access
Eligibility Criteria
Inclusion Criteria:
- signed a performed consent, older than 18 YO, clear indication for coronary angiography, palpable radial pulse
Exclusion Criteria:
- hemodynamic instability, critically ill patient, usual coronary angiography contraindication
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Angiography performed using distal radial artery
Angiography performed using proximal radial artery
Arm Description
Patients undergoing coronary angiography with or without intervention using distal radial artery ('snuff box') as a vascular access
Patients undergoing coronary angiography with or without intervention using proximal radial artery as a vascular access
Outcomes
Primary Outcome Measures
Occlusion of the radial artery
Occlusion of the radial artery used for coronary intervention diagnosed using Color Doppler
Secondary Outcome Measures
Full Information
NCT ID
NCT04232488
First Posted
January 14, 2020
Last Updated
January 15, 2020
Sponsor
University Hospital "Sestre Milosrdnice"
1. Study Identification
Unique Protocol Identification Number
NCT04232488
Brief Title
Distal vs Proximal Radial Approach for Coronary Interventions
Official Title
Comparison of the Distal Radial Approach Using a "Snuff Box" and the Proximal Radial Approach in Coronary Angiography and PCI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital "Sestre Milosrdnice"
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
The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions. This study will compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach
Detailed Description
Introduction: The distal radial approach ('snuff box' / fossa radialis) has become as valuable as the 'classical' radial approach for coronary angiography and interventions. Up to now, the success of the procedures has been described in several papers, with no difference in the complication rate and characteristics of the coronarography compared to the radial approach. It was observed that patients using distal radial access had fewer postoperative radial artery occlusions, which is particularly suitable for patients with renal disease (for preservation of the radial artery due to the potential formation of AV fistula for dialysis) and progressive coronary disease in order to preserve the radial artery for aortocoronary bypass formation. It is also potentially less likely to develop compartment syndrome and is suitable for patients with reduced forearm mobility. Since wrist immobilization during hemostatic compression is not required, the use of a distal radial approach allows for early mobilization of patients and a shorter duration of compression itself.
Aim of the study: To compare the characteristics of coronary angiography / percutaneous coronary intervention (duration of procedure, time to obtain the vascular arterial access, amount of contrast used, time and amount of radiation, success of procedure) and patency of radial arteries 3 months after the intervention using the distal ('snuff box') and proximal ('classic') radial approach Purpose of the study: to confirm the efficacy of the distal radial approach as equally effective with a lower degree of radial artery occlusion during the follow-up period Research Hypothesis: Patients using a coronary angiography / percutaneous intervention using a distal radial approach had less occlusion of the radial arteries at long-term follow-up, with no significant difference in the features of the angiography / intervention itself (duration of procedure, time to obtain the vascular access, amount of contrast used , time and amount of radiation, procedure success).
Study participants: patients undergoing coronary intervention at the Catheterization Laboratory of the Clinic for Cardiovascular Diseases at the Clinical Hospital Center "Sestre milosrdnice", Zagreb Research Methodology and Material: Standard materials and standard methods will be used to perform coronary angiography and percutaneous coronary intervention Research Plan: After signing the informed consent, the study will include 250 patients in the distal transradial approach group, and 500 patients in the proximal radial approach group (control group). The materials, as well as the procedure technique, are standardized; the characteristics of the procedure (duration of the procedure, time of obtaining the arterial access, amount of contrast used, time and amount of radiation, success of the procedure) will be observed and Doppler of the radial artery will be performed on the first following operator-specified control (usually after 3 months of the procedure) to determine the patency of the artery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Vascular Diseases
Keywords
coronary disease, snuff box, radial access
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Angiography performed using distal radial artery
Arm Type
Experimental
Arm Description
Patients undergoing coronary angiography with or without intervention using distal radial artery ('snuff box') as a vascular access
Arm Title
Angiography performed using proximal radial artery
Arm Type
Active Comparator
Arm Description
Patients undergoing coronary angiography with or without intervention using proximal radial artery as a vascular access
Intervention Type
Procedure
Intervention Name(s)
coronary angiography using distal radial artery
Intervention Description
Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using distal radial artery ('snuff box'); color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery
Intervention Type
Procedure
Intervention Name(s)
coronary angiography using proximal radial artery
Intervention Description
Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using proximal radial artery; color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery
Primary Outcome Measure Information:
Title
Occlusion of the radial artery
Description
Occlusion of the radial artery used for coronary intervention diagnosed using Color Doppler
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
signed a performed consent, older than 18 YO, clear indication for coronary angiography, palpable radial pulse
Exclusion Criteria:
hemodynamic instability, critically ill patient, usual coronary angiography contraindication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikola Kos, MD
Phone
+385989638946
Email
nikolakos89@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nikola Pavlović, MD, PhD
Email
nikolap12@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Distal vs Proximal Radial Approach for Coronary Interventions
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