The Procedural Success and Complication Rate of the Left Distal Radial Approach
1 other identifier
observational
200
1 country
1
Brief Summary
Left distal transradial approach (ldTRA) can be an attractive alternative route for left radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and safety of the use of ldTRA. But, there is few studies focused on this issue. Therefore, the purpose of this prospective observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedStudy Start
First participant enrolled
October 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2018
CompletedMay 8, 2018
May 1, 2018
4 months
September 17, 2017
May 2, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Success rate of coronary angiography
The frequency of success rate of coronary angiography (%)
1 year
Success rate of percutaneous coronary intervention
The frequency of success rate of percutaneous coronary intervention (%)
1 year
Secondary Outcomes (8)
Success rate of puncture of left distal radial artery
1 year
Diameter of left distal radial artery
1 year
Hemostasis duration at the puncture site
1 year
Complications at the puncture site
1 year
Procedure time
1 year
- +3 more secondary outcomes
Study Arms (1)
ldTRA
Patients who are planned to perform coronary angiography will be enrolled via left distal radial artery
Interventions
After puncture of left distal radial artery, coronary angiography and percutaneous coronary intervention, if needed, will be performed.
Eligibility Criteria
During 1 year, more than 200 patients who are needed to perform coronary angiography or percutaneous coronary intervention will be prospectively enrolled.
You may qualify if:
- Patients over 20 years old requiring coronary angiography
- Patients who are palpable left distal radial artery
- Patients who agreed to participate in the study
You may not qualify if:
- Patients who are not palpable left distal radial artery
- Patients who are positive in Modified Allen's test (suspicious of occlusion of ulnar artery)
- Pregnant women
- Patients who are not appropriate for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Related Publications (1)
Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.
PMID: 28506941RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Hwan Lee, MD, PhD
Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 17, 2017
First Posted
September 25, 2017
Study Start
October 11, 2017
Primary Completion
February 19, 2018
Study Completion
February 24, 2018
Last Updated
May 8, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share