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

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03854253
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Days): 16
• Patients Per Site Per Month: 190.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Procedure: Long introducer sheath; Procedure: Short introducer sheath	N/A

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

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial
• Actual Study Start Date: Feb 26, 2019
• Actual Primary Completion Date: Mar 13, 2019
• Actual Study Completion Date: Mar 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long introducer 6Fr-25cm The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm	Procedure: Long introducer sheath; The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm
Active Comparator: Short introducer 6Fr-10cm The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm	Procedure: Short introducer sheath; The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Radial Artery Occlusion [up to 10 days]

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

Secondary Outcome Measures

1. Number of Participants With a Hematoma, Stage I [up to 10 days]

   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.

2. Rate of Conversion of Needle Type [up to 10 days]

   Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.

3. Time of the Introducer Insertion [up to 10 days]

   Time from start punction of the radial artery to full insertion of the introducer

4. Time of the Procedure [up to 10 days]

   Time from insertion of the introducer to finish the procedure

5. Fluoroscopy Time [up to 10 days]

   Fluoroscopy time, sec

6. Total Air Kerma [up to 10 days]

   Total air kerma, mGy

7. Number of Participants With a Perforation / Dissection of a Radial Artery. [up to 10 days]

   Rate of access site complications during percutaneous procedures performed via a transradial approach

8. Number of Participants With Median Nerve Neuritis [up to 10 days]

   Rate of access site complications during percutaneous procedures performed via a transradial approach

9. Number of Participants With a Bleeding of the Puncture Site. [up to 10 days]

   Rate of access site complications during percutaneous procedures performed via a transradial approach.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age over 18 years old

• Applicability of transradial approach

Exclusion Criteria:

• Failure of the transradial approach

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science	Tyumen		Russian Federation	625026

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Sergey V Popov, Tomsk National Research Medical Center of the Russian Academy of Sciences

Study Documents (Full-Text)

• Study Protocol - Feb 11, 2019
• Statistical Analysis Plan - Feb 11, 2019

More Information

Publications

None provided.

• Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
• ClinicalTrials.gov Identifier: NCT03854253
• Other Study ID Numbers: IntroLength
• First Posted: Feb 26, 2019
• Last Update Posted: Jan 13, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Period Title: Overall Study
STARTED	50	50
COMPLETED	49	50
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm	Total
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm	Total of all reporting groups
Overall Participants	50	50	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	37 74%	30 60%	67 67%
>=65 years	13 26%	20 40%	33 33%
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	58.04 (11.163)	63.46 (9.265)	60.75 (10.563)
Sex: Female, Male (Count of Participants)
Female	15 30%	22 44%	37 37%
Male	35 70%	28 56%	63 63%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	50 100%	50 100%	100 100%
Region of Enrollment (participants) [Number]
Russia	50 100%	50 100%	100 100%
Signed informed consent document (Count of Participants)
Count of Participants [Participants]	50 100%	50 100%	100 100%
Repeated radial access (Count of Participants)
Count of Participants [Participants]	14 28%	19 38%	33 33%
Diabetes mellitus (Count of Participants)
Count of Participants [Participants]	11 22%	10 20%	21 21%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	31.5 (5.5)	31.8 (6.2)	31.6 (5.8)
Taking anticoagulants (Count of Participants)
Count of Participants [Participants]	11 22%	19 38%	30 30%
CAG (Count of Participants)
Count of Participants [Participants]	44 88%	39 78%	83 83%
PCI (Count of Participants)
Count of Participants [Participants]	4 8%	5 10%	9 9%
Ad hoc PCI (Count of Participants)
Count of Participants [Participants]	2 4%	6 12%	8 8%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Count of Participants [Participants]	4 8%	2 4%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Count of Participants [Participants]	8 16%	8 16%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Count of Participants [Participants]	5 10%	0 0%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Median (Inter-Quartile Range) [seconds]	94	42.5

5. Secondary Outcome

Title	Time of the Procedure
Description	Time from insertion of the introducer to finish the procedure
Time Frame	up to 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Median (Inter-Quartile Range) [seconds]	448	350.5

6. Secondary Outcome

Title	Fluoroscopy Time
Description	Fluoroscopy time, sec
Time Frame	up to 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Median (Inter-Quartile Range) [seconds]	82.0	69.5

7. Secondary Outcome

Title	Total Air Kerma
Description	Total air kerma, mGy
Time Frame	up to 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Median (Standard Deviation) [mGy]	140.8 (97.7)	128.2 (71.3)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Count of Participants [Participants]	0 0%	0 0%

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Long Introducer 6Fr-25cm	Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Measure Participants	49	50
Count of Participants [Participants]	1 2%	0 0%

Adverse Events

Time Frame	The period of time over which adverse event data were collected is 10 days.
Arm/Group Title	Long Introducer 6Fr-25cm		Short Introducer 6Fr-10cm
Arm/Group Description	The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm		The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
All Cause Mortality
	Long Introducer 6Fr-25cm		Short Introducer 6Fr-10cm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)
Serious Adverse Events
	Long Introducer 6Fr-25cm		Short Introducer 6Fr-10cm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Long Introducer 6Fr-25cm		Short Introducer 6Fr-10cm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/50 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.