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Completed

NCT Number: NCT03389503

Comparison of Left and Right Transradial Approach for CAG and PCI

This trial will compare the procedural success rate between right and left radial approach in patients undergoing coronary angiography and coronary intervention.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Ischemic Heart Disease Without Angina Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Non-ST Elevation Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction ST-segment Elevation Myocardial Infarction Signs and Symptoms Stable Angina Unstable Angina Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

About this study

The three operators who are proficient in the left radial approach for coronary angiography and coronary intervention will be assigned to the right radial approach for 3 months (phase 1). After then, these three operators will switch approach site to the left radial for another 3 months (phase 2).

Procedural success, time of the procedure, use of contrast agent, and fluoroscopic data will be compared between right radial approach (phase 1) group and left radial approach (phase 2).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects undergoing coronary angiography via radial approach
  • Subjects undergoing coronary intervention via radial approach
  • Subjects give written informed consent

Exclusion criteria

  • Subjects undergoing procedure(s) other than coronary angiography or intervention
  • Subjects with contraindication of radial approach (i.e, non-palpable radial pulsation, abnormal Allen's test, known radial artery tortuosity or occlusion, arteriovenous fistula for dialysis)

Treatment and study plan

Radial approach

Procedure

Approach site for coronary angiography and coronary intervention

Primary outcomes

  1. Procedural success

    Time frame: At the end of procedure

    Finishing coronary angiography/intervention without changing approach site

Secondary outcomes

  1. Puncture time

    Time frame: At the end of procedure

    Duration from the start of local anesthesia infiltration to the insertion of sheath

  2. Coronary angiography time

    Time frame: At the end of procedure

    Duration from the insertion of sheath to the end of coronary angiography

  3. Puncture + Coronary angiography time

    Time frame: At the end of procedure

    Sum of puncture time and coronary angiography time

  4. Coronary intervention time

    Time frame: At the end of procedure

    Duration from the end of coronary angiography to the end of coronary intervention

  5. Contrast amount during coronary angiography

    Time frame: At the end of procedure

    Amount of contrast agent used during coronary angiography

  6. Contrast amount during coronary intervention

    Time frame: At the end of procedure

    Amount of contrast agent used during coronary intervention

  7. Fluoroscopic dose, dose area product during coronary angiography

    Time frame: At the end of procedure

    Dose area product during coronary angiography

  8. Fluoroscopic dose, dose area product during coronary intervention

    Time frame: At the end of procedure

    Dose area product during coronary intervention

  9. Fluoroscopic time during coronary angiography

    Time frame: At the end of procedure

    Fluoroscopic time during coronary angiography

  10. Fluoroscopic time during coronary intervention

    Time frame: At the end of procedure

    Fluoroscopic time during coronary intervention

Sponsors and collaborators

Lead sponsor

Wonju Severance Christian Hospital

Other

Registry information

Official study title

Comparison Between Left and Right Transradial Approach During Coronary Angiography and Percutaneous Coronary Intervention

Acronym: COMPARE-Rad

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 3, 2018
Registry last updated
Jan 3, 2018

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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