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COMPLETED
NCT07572422
NA

Use of Various Types of Introducers in Conventional Radial Access

Sponsor: Pirogov Russian National Research Medical University

View on ClinicalTrials.gov

Summary

The purpose of this intervention study is to compare different types of radial introducers used in traditional radial access in terms of the incidence of complications. The main questions it aims to answer are: 1. Does a smaller outer diameter of the introducer reduce the risk of complications associated with radial access? 2. Does the presence of an outer hydrophilic coating on the introducer reduce the risk of complications associated with radial access? 3. Does the use of an introducer with a smaller outer diameter and an outer hydrophilic coating reduce the risk of complications associated with radial access? The researchers will compare the number of complications associated with radial access when using conventional diameter, uncoated radial introducers, conventional diameter introducers with an outer hydrophilic coating, or reduced outer diameter introducers with an outer hydrophilic coating. During the scheduled revascularization procedure, the participants will undergo radial artery catheterization using one of the types of introducers. Complications from the radiation access will be recorded by doctors within 72 hours after the intervention.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3307

Start Date

2019-01-28

Completion Date

2025-12-19

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

PROCEDURE

catheterization of the radial artery using an classic introducer

The right radial artery was punctured under local anesthesia with a 2% lidocaine solution. The radial artery was punctured at a typical location using a puncture needle included in the catheterization kit, puncturing only the anterior wall. An introducer with a standard outer diameter and no external hydrophilic coating was inserted. 5,000 IU of heparin in saline solution was injected into the catheterized artery. All injected solutions, including radiocontrast agents, had a temperature of 36.5-36.7 °C. Hemostasis was achieved by applying a pressure bandage. The access site was examined 3 hours after the intervention, and then, if there were no complaints, it was examined again when the bandage was removed. After the bandage was removed, patients underwent an ultrasound examination to confirm the patency of the radial artery. Complications were recorded within 3 days after the intervention.

PROCEDURE

catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coating

Description: The right radial artery was punctured under local anesthesia with a 2% lidocaine solution. The radial artery was punctured at a typical location using a puncture needle included in the catheterization kit, puncturing only the anterior wall. An introducer with a standard outer diameter and an outer hydrophilic coating was using. 5,000 IU of heparin in saline solution was injected into the catheterized artery. All injected solutions, including radiocontrast agents, had a temperature of 36.5-36.7 °C. Hemostasis was achieved by applying a pressure bandage. The access site was examined 3 hours after the intervention, and then, if there were no complaints, it was examined again when the bandage was removed. After the bandage was removed, patients underwent an ultrasound examination to confirm the patency of the radial artery. Complications were recorded within 3 days after the intervention.

PROCEDURE

catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coating

Description: The right radial artery was punctured under local anesthesia with a 2% lidocaine solution. The radial artery was punctured at a typical location using a puncture needle included in the catheterization kit, puncturing only the anterior wall. An introducer with a reduced outer diameter and an outer hydrophilic coating was using. 5,000 IU of heparin in saline solution was injected into the catheterized artery. All injected solutions, including radiocontrast agents, had a temperature of 36.5-36.7 °C. Hemostasis was achieved by applying a pressure bandage. The access site was examined 3 hours after the intervention, and then, if there were no complaints, it was examined again when the bandage was removed. After the bandage was removed, patients underwent an ultrasound examination to confirm the patency of the radial artery. Complications were recorded within 3 days after the intervention.

Locations (2)

E.I. Korolev Kostroma Regional Clinical Hospital

Kostroma, Kostroma Oblast, Russia

Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church

Moscow, Moscow, Russia