Percutaneous Coronary Intervention (PCI)TIRENCT07572422
Use of Various Types of Introducers in Conventional Radial Access
A study testing catheterization of the radial artery using an classic introducer, catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coating and catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coating in people with Percutaneous Coronary Intervention (PCI) and Radial Artery Occlusion, run by Pirogov Russian National Research Medical University at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention (PCI), Radial Artery Occlusion, Radial Artery Spasm
- What is being tested?
- catheterization of the radial artery using an classic introducer, catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coating and catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,307 participants
- Where
- 2 sitesRussia
- Study dates
- 28 Jan 2019to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clear pulsation of the right radial artery
- indications for percutaneous coronary intervention
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
E.I. Korolev Kostroma Regional Clinical Hospital
Kostroma, Kostroma Oblast, 156013
Central Clinical Hospital of St. Alexy Metropolitan of Moscow of the Moscow Patriarchate of the Russian Orthodox Church
Moscow, Moscow, 119071
About this study
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:
Read more
- Does a smaller outer diameter of the introducer reduce the risk of complications associated with radial access?
- Does the presence of an outer hydrophilic coating on the introducer reduce the risk of complications associated with radial access?
- 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.
Read the detailed description
Objective: to compare different types of radial introducers used in conventional radial access by the frequency of complications.
Scientific hypotheses:
- The risk of acute radial artery occlusion depends on the outer diameter of the introducer.
- The risk of acute radial artery occlusion depends on the presence of an outer hydrophilic coating on the introducer.
- The risk of persistent radial artery spasm depends on the presence of an outer hydrophilic coating on the introducer.
- The risk of persistent radial artery spasm depends on the outer diameter of the introducer.
Patients were enrolled by endovascular specialists with experience of at least 250 radial-access procedures per year.
Inclusion criteria: clear pulsation of the right radial artery, indications for percutaneous coronary intervention.
Exclusion criteria: 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.
The required sample size was calculated using the method of M. Bland for a high-precision study. The required significance level (α) was 0.001 and the statistical power was 95%. The expected rate of radial artery occlusion in the Rad, Rad polymer, and Rad slender groups was assumed to be 12%, 8%, and 8%, respectively. Under these conditions, the calculated sample size was 2723 patients. The planned loss during the study was 20%. Thus, the minimum sample size was 3268 patients.
The study had an experimental design and complied with the CONSORT protocol. A simple randomization method using a random-number generator was chosen. The type of randomization was permuted block randomization. The total block size was 3000, and the allocation ratio between the groups was 1:1:0.7.
Puncture of the right radial artery was performed after local anesthesia with a 2% lidocaine solution. The radial artery was punctured at the typical site using the puncture needle included in the introducer set, with only the anterior wall being punctured. The type of introducer was selected by randomization using a random-number method, and depending on this assignment the patient was allocated to one of the groups.
All patients underwent percutaneous coronary angioplasty with coronary artery stenting via the right radial artery. The radial artery catheterization technique did not differ between groups. The type of introducer was selected by randomization using a random-number method, and depending on this assignment the patient was allocated to one of the groups. In the Rad group , introducers without a hydrophilic coating were used; in the Rad polymer group , introducers with a hydrophilic coating were used; and in the Rad slender group , thin-walled introducers with a hydrophilic coating were used. The access site was examined within 3 hours after the intervention and then, in the absence of complaints, again at bandage removal. After bandage removal, patients underwent ultrasound examination to confirm radial artery patency. Complications from the radiation access will be recorded by doctors within 72 hours after the intervention.
- Being tested
- catheterization of the radial artery using an classic introducer, catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coating, catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coating
- Keywords
- radial access, types of radial introducers, Radial Artery Spasm, Percutaneous Coronary Intervention (PCI), Radial artery occlusion, Randomized study
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catheterization of the radial artery using an classic introducerProcedure or surgery
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.
catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coatingProcedure or surgery
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.
catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coatingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Rad classic | Active comparator | Introducer with a standard outer diameter and no external hydrophilic coating Receives: Procedure: catheterization of the radial artery using an classic introducer |
| Rad polymer | Experimental | Introducer with a standard outer diameter and an outer hydrophilic coating Receives: 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 Receives: Procedure: catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute radial artery occlusion after catheterization
Acute radial artery occlusion was confirmed by ultrasound examination
Measured: Within 72 hours after radial artery catheterization
Radial artery perforation
Angiography-confirmed perforation of the radial artery
Measured: Perioperative/Periprocedural
Radial artery false aneurysm
A false aneurysm of the radial artery was confirmed by ultrasound examination
Measured: Within 72 hours after radial artery catheterization
Hematoma by classification EASY Grade II
Hematoma by classification EASY Grade II was confirmed by ultrasound examination
Measured: Within 72 hours after radial artery catheterization
Persistent radial artery spasm
Persistent radial artery spasm confirmed by angiography
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start28 Jan 2019
- Primary completion16 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary Intervention (PCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3,307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Responsible party
- Principal investigator, Aleksandr V. Bocharov, PhD, MD, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572422
- Sponsor's protocol ID
- 260/1
- Acronym
- TIRE
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all personal data underlying the publication results
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Various Types of Introducers in Conventional Radial Access
- ClinicalTrials.gov ID
- NCT07572422
- Acronym / sponsor ID
- TIRE / 260/1
- Keywords
- radial access, types of radial introducers, Radial Artery Spasm, Percutaneous Coronary Intervention (PCI), Radial artery occlusion, Randomized study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,307 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Collaborators
- I.M. Sechenov First Moscow State Medical University
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a smaller outer diameter of the introducer reduce the risk of complications associated with radial access?
- Does the presence of an outer hydrophilic coating on the introducer reduce the risk of complications associated with radial access?
- 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.
Detailed description
Objective: to compare different types of radial introducers used in conventional radial access by the frequency of complications.
Scientific hypotheses:
- The risk of acute radial artery occlusion depends on the outer diameter of the introducer.
- The risk of acute radial artery occlusion depends on the presence of an outer hydrophilic coating on the introducer.
- The risk of persistent radial artery spasm depends on the presence of an outer hydrophilic coating on the introducer.
- The risk of persistent radial artery spasm depends on the outer diameter of the introducer.
Patients were enrolled by endovascular specialists with experience of at least 250 radial-access procedures per year.
Inclusion criteria: clear pulsation of the right radial artery, indications for percutaneous coronary intervention.
Exclusion criteria: 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.
The required sample size was calculated using the method of M. Bland for a high-precision study. The required significance level (α) was 0.001 and the statistical power was 95%. The expected rate of radial artery occlusion in the Rad, Rad polymer, and Rad slender groups was assumed to be 12%, 8%, and 8%, respectively. Under these conditions, the calculated sample size was 2723 patients. The planned loss during the study was 20%. Thus, the minimum sample size was 3268 patients.
The study had an experimental design and complied with the CONSORT protocol. A simple randomization method using a random-number generator was chosen. The type of randomization was permuted block randomization. The total block size was 3000, and the allocation ratio between the groups was 1:1:0.7.
Puncture of the right radial artery was performed after local anesthesia with a 2% lidocaine solution. The radial artery was punctured at the typical site using the puncture needle included in the introducer set, with only the anterior wall being punctured. The type of introducer was selected by randomization using a random-number method, and depending on this assignment the patient was allocated to one of the groups.
All patients underwent percutaneous coronary angioplasty with coronary artery stenting via the right radial artery. The radial artery catheterization technique did not differ between groups. The type of introducer was selected by randomization using a random-number method, and depending on this assignment the patient was allocated to one of the groups. In the Rad group , introducers without a hydrophilic coating were used; in the Rad polymer group , introducers with a hydrophilic coating were used; and in the Rad slender group , thin-walled introducers with a hydrophilic coating were used. The access site was examined within 3 hours after the intervention and then, in the absence of complaints, again at bandage removal. After bandage removal, patients underwent ultrasound examination to confirm radial artery patency. Complications from the radiation access will be recorded by doctors within 72 hours after the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rad classic | Active comparator | Procedure: catheterization of the radial artery using an classic introducerIntroducer with a standard outer diameter and no external hydrophilic coating |
| Rad polymer | Experimental | Procedure: catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coatingIntroducer with a standard outer diameter and an outer hydrophilic coating |
| Rad slender | Experimental | Procedure: catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coatingIntroducer with a reduced outer diameter and an outer hydrophilic coating |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clear pulsation of the right radial artery
- indications for percutaneous coronary intervention
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| catheterization of the radial artery using an classic introducerThe 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 or surgery | Rad classic |
| catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coatingDescription: 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 or surgery | Rad polymer |
| catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coatingDescription: 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. | Procedure or surgery | Rad slender |
Primary outcome
Acute radial artery occlusion after catheterization
Time frame: Within 72 hours after radial artery catheterization
Acute radial artery occlusion was confirmed by ultrasound examination
Radial artery perforation
Time frame: Perioperative/Periprocedural
Angiography-confirmed perforation of the radial artery
Radial artery false aneurysm
Time frame: Within 72 hours after radial artery catheterization
A false aneurysm of the radial artery was confirmed by ultrasound examination
Hematoma by classification EASY Grade II
Time frame: Within 72 hours after radial artery catheterization
Hematoma by classification EASY Grade II was confirmed by ultrasound examination
Persistent radial artery spasm
Time frame: Perioperative/Periprocedural
Persistent radial artery spasm confirmed by angiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. all personal data underlying the publication results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catheterization of the radial artery using an classic introducer, catheterization of the radial artery using an introducer with a standard outer diameter and an outer hydrophilic coating and catheterization of the radial artery using an introducer with a reduced outer diameter and an outer hydrophilic coating in people with Percutaneous Coronary Intervention (PCI) and Radial Artery Occlusion, run by Pirogov Russian National Research Medical University at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute radial artery occlusion after catheterization (time frame: Within 72 hours after radial artery catheterization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.