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Completed

NCT Number: NCT03854253

Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures

This study evaluates estimate impact of introducers length during endovascular coronary procedures on rate of a radial artery occlusion. For half of participants will use short introducers, while for other will use long introducers during transradial coronary intervention.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Tyumen, 625026, Russia

About this study

The transradial approach for coronary angiography and interventions is increasingly utilized around the world. Radial artery occlusion is the most common significant complication after transradial catheterization, with incidence varying between 1% and 10%. Endothelial injury of the radial artery and decrease in blood flow after sheath and catheter insertion appear to contribute to thrombus formation and are predisposing factors for radial artery occlusion. Procedural factors can predict and influence radial artery occlusion incidence. Sheath size and its relation to radial artery diameter, as well as the utilization of specific pharmacological agents (such as anticoagulants and vasodilators) have been studied. But, impact of Introducer sheath length on the rate of a radial artery occlusion has not been studied. The investigators suggest that, longer introducer sheath sizes can prevented the vascular damage and a pro-thrombotic environment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age over 18 years old
  • Applicability of transradial approach

Exclusion criteria

  • Failure of the transradial approach

Treatment and study plan

Long introducer sheath

Procedure

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm

Short introducer sheath

Procedure

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm

Primary outcomes

  1. Number of Participants With Radial Artery Occlusion

    Time frame: up to 10 days

    Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.

Secondary outcomes

  1. Number of Participants With a Hematoma, Stage I

    Time frame: up to 10 days

    Rate of access site complications during percutaneous procedures performed via a transradial approach. Local hematomas are classified according to the following scale: I - diameter not more than 5 cm, II - not more than 10 cm, III - not more than 10 cm, but not higher than the elbow, IV - above the elbow, V - with the threat of hand ischemia [Bertrand, O. F., De Larochelliere, R., Rodes-Cabau, J., Proulx, G., Gleeton, O., Manh Nguyen, C., Dery J.P., Barbeau G., Noel B., Larose E., Poirier P., Roy L. A Randomized Study Comparing Same-Day Home Discharge and Abciximab Bolus Only to Overnight Hospitalization and Abciximab Bolus and Infusion After Transradial Coronary Stent Implantation. Circulation, 2006 114(24), 2636-2643.doi:10.1161/circulationaha.106.638627]. Hematomas more than stage I were not recorded in both groups.

  2. Rate of Conversion of Needle Type

    Time frame: up to 10 days

    Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.

  3. Time of the Introducer Insertion

    Time frame: up to 10 days

    Time from start punction of the radial artery to full insertion of the introducer

  4. Time of the Procedure

    Time frame: up to 10 days

    Time from insertion of the introducer to finish the procedure

  5. Fluoroscopy Time

    Time frame: up to 10 days

    Fluoroscopy time, sec

  6. Total Air Kerma

    Time frame: up to 10 days

    Total air kerma, mGy

  7. Number of Participants With a Perforation / Dissection of a Radial Artery.

    Time frame: up to 10 days

    Rate of access site complications during percutaneous procedures performed via a transradial approach

  8. Number of Participants With Median Nerve Neuritis

    Time frame: up to 10 days

    Rate of access site complications during percutaneous procedures performed via a transradial approach

  9. Number of Participants With a Bleeding of the Puncture Site.

    Time frame: up to 10 days

    Rate of access site complications during percutaneous procedures performed via a transradial approach.

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial

Acronym: IntroLength

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2019
Registry last updated
Jun 24, 2026

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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