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

October 8, 2023 updated by: Wujin People's Hospital

Comparison of the Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal vs Conventional Radial Approach: Randomized-controlled Trial(CONDITION)

Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

801

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213017
        • Changzhou Wujin People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: distal radial approach group
subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach
Procedure: distal radial approach
coronary diagnosis and intervention via distal vs conventional radial approach
Active Comparator: conventional radial access group
subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach
Procedure: conventional radial access
conventional radial access

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term radial artery occlusion
Time Frame: 3 months after procedure
Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 3 months after procedure
3 months after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radial artery occlusion
Time Frame: at 24 hours after procedure
Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure
at 24 hours after procedure
success rate of puncture
Time Frame: at 24 hours post procedure
Success of puncture is defined as the sheath inserted into the artery
at 24 hours post procedure
time of puncture
Time Frame: at 24 hours post procedure
time of puncture is defined as the time from initial puncture to the sheath inserted into the artery
at 24 hours post procedure
Radial artery trauma
Time Frame: at 24 hours and 3 months post procedure
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
at 24 hours and 3 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wujin People's Hospital

Investigators

  • Study Chair: Gaojun Cai, MD, Cardiovascular department, Changzhou Wujin People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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