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Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION) (CONDITION)

Primary Purpose

Coronary Artery Disease, Distal Radial Artery, Radial Artery Occlusion

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
distal radial approach
conventional radial access
Sponsored by
Wujin People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring coronary artery disease, distal radial artery, conventional radial artery, radial artery occlusion

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years;
  • Palpable unilateral distal radial and radial artery

Exclusion Criteria:

  • Age ≥ 90years;
  • Height≥ 185cm;
  • Cardiogenic shock;
  • Contraindications to puncture at the puncture site;
  • Inability to obtain written informed consent

Sites / Locations

  • Changzhou Wujin People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

distal radial approach group

conventional radial access group

Arm Description

subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach

subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach

Outcomes

Primary Outcome Measures

long-term radial artery occlusion
Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 3 months after procedure

Secondary Outcome Measures

radial artery occlusion
Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure
success rate of puncture
Success of puncture is defined as the sheath inserted into the artery
time of puncture
time of puncture is defined as the time from initial puncture to the sheath inserted into the artery
Radial artery trauma
Number of participants with radial artery trauma in the radial and distal radial artery, such as the intimal tears, dissections, thrombosis, and pseudoaneurysms in the radial and distal radial artery, which is detected by ultrasound

Full Information

First Posted
February 3, 2022
Last Updated
October 8, 2023
Sponsor
Wujin People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05253820
Brief Title
Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)
Acronym
CONDITION
Official Title
Comparison of the Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal vs Conventional Radial Approach: Randomized-controlled Trial(CONDITION)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wujin People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach
Detailed Description
Coronary diagnosis and intervention via distal radial artery is prevalent worldwide. This study aims to explore the long-term radial artery occlusion after coronary diagnosis and intervention via distal radial artery at 3 months after procedure using portable high-frequent ultrasound. The secondary endpoints include the success rate of puncture, time of puncture, duration of hemostasis, radial artery trauma, etc.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Distal Radial Artery, Radial Artery Occlusion
Keywords
coronary artery disease, distal radial artery, conventional radial artery, radial artery occlusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center parallel randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
801 (Actual)

8. Arms, Groups, and Interventions

Arm Title
distal radial approach group
Arm Type
Experimental
Arm Description
subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach
Arm Title
conventional radial access group
Arm Type
Active Comparator
Arm Description
subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach
Intervention Type
Procedure
Intervention Name(s)
distal radial approach
Intervention Description
coronary diagnosis and intervention via distal vs conventional radial approach
Intervention Type
Procedure
Intervention Name(s)
conventional radial access
Intervention Description
conventional radial access
Primary Outcome Measure Information:
Title
long-term radial artery occlusion
Description
Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 3 months after procedure
Time Frame
3 months after procedure
Secondary Outcome Measure Information:
Title
radial artery occlusion
Description
Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure
Time Frame
at 24 hours after procedure
Title
success rate of puncture
Description
Success of puncture is defined as the sheath inserted into the artery
Time Frame
at 24 hours post procedure
Title
time of puncture
Description
time of puncture is defined as the time from initial puncture to the sheath inserted into the artery
Time Frame
at 24 hours post procedure
Title
Radial artery trauma
Description
Number of participants with radial artery trauma in the radial and distal radial artery, such as the intimal tears, dissections, thrombosis, and pseudoaneurysms in the radial and distal radial artery, which is detected by ultrasound
Time Frame
at 24 hours and 3 months post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years; Palpable unilateral distal radial and radial artery Exclusion Criteria: Age ≥ 90years; Height≥ 185cm; Cardiogenic shock; Contraindications to puncture at the puncture site; Inability to obtain written informed consent Previous right radial or distal artery intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaojun Cai, MD
Organizational Affiliation
Cardiovascular department, Changzhou Wujin People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Changzhou Wujin People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213017
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33932290
Citation
Gupta A, Agstam S. Radial Artery Pseudoaneurysm Following Percutaneous Coronary Intervention. J Invasive Cardiol. 2021 May;33(5):E406.
Results Reference
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Citation
Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002686. doi: 10.1161/JAHA.115.002686.
Results Reference
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PubMed Identifier
34107564
Citation
Tehrani DM, Seto AH. Heparin, compression, and radial artery occlusion: Less is more. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):1377-1378. doi: 10.1002/ccd.29764. No abstract available.
Results Reference
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PubMed Identifier
31380781
Citation
Hadjivassiliou A, Kiemeneij F, Nathan S, Klass D. Ultrasound-guided access to the distal radial artery at the anatomical snuffbox for catheter-based vascular interventions: a technical guide. EuroIntervention. 2021 Mar 19;16(16):1342-1348. doi: 10.4244/EIJ-D-19-00555.
Results Reference
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PubMed Identifier
28506941
Citation
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.
Results Reference
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PubMed Identifier
33349158
Citation
Soydan E, Akin M. Applicability of left distal radial artery access site in ST-segment elevation myocardial infarction; A comparative evaluation with the conventional transfemoral approach. J Vasc Access. 2022 Jan;23(1):81-87. doi: 10.1177/1129729820983138. Epub 2020 Dec 21.
Results Reference
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PubMed Identifier
33035178
Citation
Colletti G, Auslender J, De Meester A, Aminian A, Kayaert P, Ungureanu C. Feasibility and Safety of Performing Complex Coronary Interventions by Distal Radial Artery Using the Railway Sheathless Vascular System. J Invasive Cardiol. 2020 Dec;32(12):459-462. Epub 2020 Oct 10.
Results Reference
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PubMed Identifier
33380922
Citation
Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.
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PubMed Identifier
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Citation
Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.
Results Reference
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PubMed Identifier
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Citation
Mhanna M, Beran A, Nazir S, Al-Abdouh A, Barbarawi M, Sajdeya O, Ayesh H, Nesheiwat Z, Malhas SE, Eltahawy EA. Outcomes of distal versus conventional transradial access for coronary angiography and intervention: An updated systematic review and meta-analysis. Int J Cardiol. 2021 Dec 1;344:47-53. doi: 10.1016/j.ijcard.2021.10.003. Epub 2021 Oct 6.
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)

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