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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Long introducer sheath; Procedure: Short introducer sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT03854253

IntroLength

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years old
• Applicability of transradial approach

Exclusion criteria

• Failure of the transradial approach

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Long introducer 6Fr-25cm

Experimental group

Description:

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

Treatment:

Procedure: Long introducer sheath

Short introducer 6Fr-10cm

Active Comparator group

Description:

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

Treatment:

Procedure: Short introducer sheath