Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures

NCT03854253 | Completed Results DMC

• 1 other identifier: IntroLength
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Radial Artery Occlusion

  Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.

  up to 10 days

Secondary Outcomes (9)

• Number of Participants With a Hematoma, Stage I

  up to 10 days

• Rate of Conversion of Needle Type

  up to 10 days

• Time of the Introducer Insertion

  up to 10 days

• Time of the Procedure

  up to 10 days

• Fluoroscopy Time

  up to 10 days

Study Arms (2)

Long introducer 6Fr-25cm

EXPERIMENTAL

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm

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

Procedure: Short introducer sheath

Interventions

Long introducer sheath PROCEDURE

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm

Long introducer 6Fr-25cm

Short introducer sheath PROCEDURE

The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm

Short introducer 6Fr-10cm

Eligibility Criteria

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

You may qualify if:

• Age over 18 years old
• Applicability of transradial approach

You may not qualify if:

• Failure of the transradial approach

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Tyumen, 625026, Russia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

For the analysis of results in the main group, 1 participant was unavailable due to transfer to another hospital because of developed acute cerebrovascular accident.

Results Point of Contact

• Title: Dr. Stanislav Sapozhnikov
• Organization: Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science, Tomsk, Russia

stas_ss@bk.ru

+79091919191

Study Officials

• Sergey V Popov

  Tomsk National Research Medical Center of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 26, 2019
• Study Start: February 26, 2019
• Primary Completion: March 13, 2019
• Study Completion: March 14, 2019
• Last Updated: January 13, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)