Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
Primary Purpose
Coronary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coronary Angiography and Intervention
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Disease focused on measuring Distal radial artery, Radial access
Eligibility Criteria
Inclusion Criteria:
- Patient is over 18 years of age.
- Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
- Patient has provided written informed consent.
- Patient is willing to comply with all protocol-required evaluations during the hospitalization.
Exclusion Criteria:
- No palpable radial artery or distal radial artery.
- Radial artery used as a bridging vessel.
- Severe heart failure (NYHA class IV).
- Severe renal insufficiency ( SCr>443umol/L).
- Height over 185 cm.
- A ≥7F catheter may be required for operation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dTRA group
cTRA group
Arm Description
Outcomes
Primary Outcome Measures
Radial artery occlusion
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04784078
Brief Title
Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
Official Title
Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner.
It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time.
Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Distal radial artery, Radial access
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
938 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dTRA group
Arm Type
Experimental
Arm Title
cTRA group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Coronary Angiography and Intervention
Intervention Description
Transradial access puncture site
Primary Outcome Measure Information:
Title
Radial artery occlusion
Description
Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.
Time Frame
Within 24 hours after the procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient is over 18 years of age.
Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
Patient has provided written informed consent.
Patient is willing to comply with all protocol-required evaluations during the hospitalization.
Exclusion Criteria:
No palpable radial artery or distal radial artery.
Radial artery used as a bridging vessel.
Severe heart failure (NYHA class IV).
Severe renal insufficiency ( SCr>443umol/L).
Height over 185 cm.
A ≥7F catheter may be required for operation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lixia Yang, Doctor
Phone
13661339066
Email
ylx966@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yujie Zhou, Doctor
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32553614
Citation
Nikolakopoulos I, Vemmou E, Brilakis ES. Distal radial access for cardiac catheterization: When and how. Hellenic J Cardiol. 2020 Mar-Apr;61(2):110-111. doi: 10.1016/j.hjc.2020.06.001. Epub 2020 Jun 14. No abstract available.
Results Reference
background
PubMed Identifier
31227393
Citation
Liontou C, Kontopodis E, Oikonomidis N, Maniotis C, Tassopoulos A, Tsiafoutis I, Lazaris E, Koutouzis M. Distal Radial Access: A Review Article. Cardiovasc Revasc Med. 2020 Mar;21(3):412-416. doi: 10.1016/j.carrev.2019.06.003. Epub 2019 Jun 8.
Results Reference
result
PubMed Identifier
30336816
Citation
Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.
Results Reference
result
PubMed Identifier
30314833
Citation
Koutouzis M, Kontopodis E, Tassopoulos A, Tsiafoutis I, Katsanou K, Rigatou A, Didagelos M, Andreou K, Lazaris E, Oikonomidis N, Maniotis C, Ziakas A. Distal Versus Traditional Radial Approach for Coronary Angiography. Cardiovasc Revasc Med. 2019 Aug;20(8):678-680. doi: 10.1016/j.carrev.2018.09.018. Epub 2018 Oct 2.
Results Reference
result
PubMed Identifier
31675155
Citation
Xenogiannis I, Brilakis ES. Distal radial access at the anatomic snuffbox: The new standard for left radial access? Catheter Cardiovasc Interv. 2019 Nov 1;94(5):658-659. doi: 10.1002/ccd.28551. No abstract available.
Results Reference
result
Learn more about this trial
Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
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