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Completed

NCT Number: NCT05253820

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

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Distal Radial Artery Heart Diseases Myocardial Ischemia Radial Artery Occlusion Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changzhou Wujin People's Hospital

Changzhou, Jiangsu, 213017, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

distal radial approach

Procedure

coronary diagnosis and intervention via distal vs conventional radial approach

conventional radial access

Procedure

conventional radial access

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. success rate of puncture

    Time frame: at 24 hours post procedure

    Success of puncture is defined as the sheath inserted into the artery

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Wujin People's Hospital

Other

Registry information

Official study title

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

Acronym: CONDITION

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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