Clinical trial NCT03854253: Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures
Official title: Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* Applicability of transradial approach

Exclusion Criteria:

* Failure of the transradial approach

Primary outcomes:
measure: Number of Participants With Radial Artery Occlusion
timeFrame: up to 10 days
Secondary outcomes:
measure: Number of Participants With a Hematoma, Stage I
timeFrame: up to 10 days
measure: Rate of Conversion of Needle Type
timeFrame: up to 10 days
measure: Time of the Introducer Insertion
timeFrame: up to 10 days
measure: Time of the Procedure
timeFrame: up to 10 days
measure: Fluoroscopy Time
timeFrame: up to 10 days
measure: Total Air Kerma
timeFrame: up to 10 days
measure: Number of Participants With a Perforation / Dissection of a Radial Artery.
timeFrame: up to 10 days
measure: Number of Participants With Median Nerve Neuritis
timeFrame: up to 10 days
measure: Number of Participants With a Bleeding of the Puncture Site.
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Study officials:
affiliation: Tomsk National Research Medical Center of the Russian Academy of Sciences
name: Sergey V Popov
role: PRINCIPAL_INVESTIGATOR
References: