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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Long introducer sheath
* Procedure: Short introducer sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years old Applicability of transradial approach Exclusion Criteria: Failure of the transradial approach

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Radial Artery Occlusion | Participants who diagnosed a radial artery occlusion with color Doppler ultrasound. | up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 10 days | 
| Time of the Introducer Insertion | Time from start punction of the radial artery to full insertion of the introducer | up to 10 days | 
| Time of the Procedure | Time from insertion of the introducer to finish the procedure | up to 10 days | 
| Fluoroscopy Time | Fluoroscopy time, sec | up to 10 days | 
| Total Air Kerma | Total air kerma, mGy | 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 | up to 10 days | 
| Number of Participants With Median Nerve Neuritis | Rate of access site complications during percutaneous procedures performed via a transradial approach | 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. | up to 10 days |