Coronary Artery DiseaseIntroLengthNCT03854253
Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures
A study testing Long introducer sheath and Short introducer sheath in people with Coronary Artery Disease, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Long introducer sheath and Short introducer sheath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 26 Feb 2019to 14 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age over 18 years old
- Applicability of transradial approach
Who cannot join
- Failure of the transradial approach
Trial locations and contacts
1 site in 1 country.
Russia1 site
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, 625026
About this study
Official title: Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Long introducer sheath, Short introducer sheath
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long introducer sheathProcedure or surgery
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm
Short introducer sheathProcedure or surgery
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
| Study group | Role | What they receive |
|---|---|---|
| Long introducer 6Fr-25cm | Experimental | The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Receives: Procedure: Long introducer sheath |
| Short introducer 6Fr-10cm | Active comparator | The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Receives: Procedure: Short introducer sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Radial Artery Occlusion
Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.
Measured: up to 10 days
Secondary outcomes (9)
Number of Participants With a Hematoma, Stage I
Rate of access site complications during percutaneous procedures performed via a transradial approach. Local hematomas are classified according to the following scale: I - diameter not more than 5 cm, II - not more than 10 cm, III - not more than 10 cm, but not higher than the elbow, IV - above the elbow, V - with the threat of hand ischemia [Bertrand, O. F., De Larochelliere, R., Rodes-Cabau, J., Proulx, G., Gleeton, O., Manh Nguyen, C., Dery J.P., Barbeau G., Noel B., Larose E., Poirier P., Roy L. A Randomized Study Comparing Same-Day Home Discharge and Abciximab Bolus Only to Overnight Hospitalization and Abciximab Bolus and Infusion After Transradial Coronary Stent Implantation. Circulation, 2006 114(24), 2636-2643.doi:10.1161/circulationaha.106.638627]. Hematomas more than stage I were not recorded in both groups.
Measured: up to 10 days
Rate of Conversion of Needle Type
Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.
Measured: up to 10 days
Time of the Introducer Insertion
Time from start punction of the radial artery to full insertion of the introducer
Measured: up to 10 days
Time of the Procedure
Time from insertion of the introducer to finish the procedure
Measured: up to 10 days
Fluoroscopy Time
Fluoroscopy time, sec
Measured: up to 10 days
Total Air Kerma
Total air kerma, mGy
Measured: up to 10 days
Number of Participants With a Perforation / Dissection of a Radial Artery.
Rate of access site complications during percutaneous procedures performed via a transradial approach
Measured: up to 10 days
Number of Participants With Median Nerve Neuritis
Rate of access site complications during percutaneous procedures performed via a transradial approach
Measured: up to 10 days
Number of Participants With a Bleeding of the Puncture Site.
Rate of access site complications during percutaneous procedures performed via a transradial approach.
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start26 Feb 2019
- Primary completion13 Mar 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergey V Popov, Principal investigator, Tomsk National Research Medical Center of the Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854253
- Sponsor's protocol ID
- TCRC-146
- Acronym
- IntroLength
- Status last verified
- Jun 2026
- First submitted
- 21 Feb 2019
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03854253
- Acronym / sponsor ID
- IntroLength / TCRC-146
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long introducer 6Fr-25cm | Experimental | Procedure: Long introducer sheathThe investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm |
| Short introducer 6Fr-10cm | Active comparator | Procedure: Short introducer sheathThe investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years old
- Applicability of transradial approach
Key exclusion criteria (1 listed)
- Failure of the transradial approach
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 |
|---|---|---|
| Long introducer sheathThe investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm | Procedure or surgery | Long introducer 6Fr-25cm |
| Short introducer sheathThe investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm | Procedure or surgery | Short introducer 6Fr-10cm |
Primary outcome
Number of Participants With Radial Artery Occlusion
Time frame: up to 10 days
Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.
9 secondary outcomes
Number of Participants With a Hematoma, Stage I
Time frame: up to 10 days
Rate of Conversion of Needle Type
Time frame: up to 10 days
Time of the Introducer Insertion
Time frame: up to 10 days
Time of the Procedure
Time frame: up to 10 days
Fluoroscopy Time
Time frame: up to 10 days
Total Air Kerma
Time frame: up to 10 days
Number of Participants With a Perforation / Dissection of a Radial Artery.
Time frame: up to 10 days
Number of Participants With Median Nerve Neuritis
Time frame: up to 10 days
Number of Participants With a Bleeding of the Puncture Site.
Time frame: up to 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sergey V Popov principal investigator
Tomsk National Research Medical Center of the Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long introducer sheath and Short introducer sheath in people with Coronary Artery Disease, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site 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 1 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Radial Artery Occlusion (time frame: up to 10 days). 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 24 Jun 2026.