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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Long introducer sheath
Short introducer sheath
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age over 18 years old
  • Applicability of transradial approach

Exclusion Criteria:

  • Failure of the transradial approach

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long introducer 6Fr-25cm

Short introducer 6Fr-10cm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants With Radial Artery Occlusion
Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.

Secondary Outcome Measures

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.
Rate of Conversion of Needle Type
Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.
Time of the Introducer Insertion
Time from start punction of the radial artery to full insertion of the introducer
Time of the Procedure
Time from insertion of the introducer to finish the procedure
Fluoroscopy Time
Fluoroscopy time, sec
Total Air Kerma
Total air kerma, mGy
Number of Participants With a Perforation / Dissection of a Radial Artery.
Rate of access site complications during percutaneous procedures performed via a transradial approach
Number of Participants With Median Nerve Neuritis
Rate of access site complications during percutaneous procedures performed via a transradial approach
Number of Participants With a Bleeding of the Puncture Site.
Rate of access site complications during percutaneous procedures performed via a transradial approach.

Full Information

First Posted
February 21, 2019
Last Updated
January 10, 2020
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03854253
Brief Title
Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures
Acronym
IntroLength
Official Title
Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
March 13, 2019 (Actual)
Study Completion Date
March 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Long introducer 6Fr-25cm
Arm Type
Experimental
Arm Description
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm
Arm Title
Short introducer 6Fr-10cm
Arm Type
Active Comparator
Arm Description
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm
Intervention Type
Procedure
Intervention Name(s)
Long introducer sheath
Intervention Description
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm
Intervention Type
Procedure
Intervention Name(s)
Short introducer sheath
Intervention Description
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Primary Outcome Measure Information:
Title
Number of Participants With Radial Artery Occlusion
Description
Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.
Time Frame
up to 10 days
Secondary Outcome Measure Information:
Title
Number of Participants With a Hematoma, Stage I
Description
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.
Time Frame
up to 10 days
Title
Rate of Conversion of Needle Type
Description
Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.
Time Frame
up to 10 days
Title
Time of the Introducer Insertion
Description
Time from start punction of the radial artery to full insertion of the introducer
Time Frame
up to 10 days
Title
Time of the Procedure
Description
Time from insertion of the introducer to finish the procedure
Time Frame
up to 10 days
Title
Fluoroscopy Time
Description
Fluoroscopy time, sec
Time Frame
up to 10 days
Title
Total Air Kerma
Description
Total air kerma, mGy
Time Frame
up to 10 days
Title
Number of Participants With a Perforation / Dissection of a Radial Artery.
Description
Rate of access site complications during percutaneous procedures performed via a transradial approach
Time Frame
up to 10 days
Title
Number of Participants With Median Nerve Neuritis
Description
Rate of access site complications during percutaneous procedures performed via a transradial approach
Time Frame
up to 10 days
Title
Number of Participants With a Bleeding of the Puncture Site.
Description
Rate of access site complications during percutaneous procedures performed via a transradial approach.
Time Frame
up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 18 years old Applicability of transradial approach Exclusion Criteria: Failure of the transradial approach
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey V Popov
Organizational Affiliation
Tomsk National Research Medical Center of the Russian Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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