Use of Various Types of Introducers in Conventional Radial Access

NCT07572422 | Completed DMC

• 1 other identifier: 260/1
• Study Type: interventional
• Target: 3,307
• Locations: 1 country
• Sites: 2

Brief 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. 1.Does a smaller outer diameter of the introducer reduce the risk of complications associated with radial access?
2. 2.Does the presence of an outer hydrophilic coating on the introducer reduce the risk of complications associated with radial access?
3. 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.

Conditions

Percutaneous Coronary Intervention (PCI); Radial Artery Occlusion; Radial Artery Spasm

Keywords

radial access; types of radial introducers; Radial Artery Spasm; Percutaneous Coronary Intervention (PCI); Radial artery occlusion; Randomized study

Outcome Measures

Primary Outcomes (5)

• Acute radial artery occlusion after catheterization

  Acute radial artery occlusion was confirmed by ultrasound examination

  Within 72 hours after radial artery catheterization

• Radial artery perforation

  Angiography-confirmed perforation of the radial artery

  Perioperative/Periprocedural

• Radial artery false aneurysm

  A false aneurysm of the radial artery was confirmed by ultrasound examination

  Within 72 hours after radial artery catheterization

• Hematoma by classification EASY Grade II

  Hematoma by classification EASY Grade II was confirmed by ultrasound examination

  Within 72 hours after radial artery catheterization

• Persistent radial artery spasm

  Persistent radial artery spasm confirmed by angiography

  Perioperative/Periprocedural

Study Arms (3)

Rad classic

ACTIVE COMPARATOR

Introducer with a standard outer diameter and no external hydrophilic coating

Procedure: catheterization of the radial artery using an classic introducer

Rad polymer

EXPERIMENTAL

Introducer with a standard outer diameter and an outer hydrophilic coating

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

Rad slender

EXPERIMENTAL

Introducer with a reduced outer diameter and an outer hydrophilic coating

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

Interventions

catheterization of the radial artery using an classic introducer PROCEDURE

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.

Rad classic

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

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.

Rad polymer

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

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.

Rad slender

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clear pulsation of the right radial artery
• indications for percutaneous coronary intervention

You may not qualify if:

• previous unsuccessful radial artery catheterization
• concomitant pathology limiting patient survival
• disorders of the blood coagulation system (hemophilia, thrombocytopathy, etc.)
• previous coronary artery bypass grafting
• occlusion of the right radial artery

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: collaborator
• Pirogov Russian National Research Medical University: lead

Study Sites (2)

E.I. Korolev Kostroma Regional Clinical Hospital

Kostroma, Kostroma Oblast, 156013, Russia

Location

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

Moscow, Moscow, 119071, Russia

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, PhD, MD

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 7, 2026
• Study Start: January 28, 2019
• Primary Completion: December 16, 2025
• Study Completion: December 19, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 6 months and ending 1 years after the publication of results

Locations

RU (2)