Novel Angioplasty Using Coronary Accessor

Study Overview
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Brief Summary
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To investigate the advantage of using a 4Fr guiding catheter over a 6 Fr, frequencies of radial artery occlusion after transradial coronary intervention (TRI) will be evaluated. Radial artery occlusion rate in 4 Fr TRI group is expected to be not more than that in 6Fr groups.

Detailed Description
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Prerequisites for TRI were a sufficiently pulsating radial artery and presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia according to the Allen's test. Exclusion criteria for the current study included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter. Patency of the radial artery after TRI will be evaluated by pulsation of the radial artery, and frequencies of which will be compared between those receiving 4Fr vs 6 Fr coronary interventions.

Official Title
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Novel Angioplasty USIng Coronary Accessor

Conditions
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Patency of the Radial Artery

Intervention / Treatment
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* Procedure: PCI (percutaneous coronary intervention)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prerequisites for transradial intervention were a sufficiently pulsating radial artery and presence of an ulnar pulse with a sufficient palmar arch, as evidenced by the absence of digital ischemia according to the Allen's test. Exclusion Criteria: Exclusion criteria included planned use of a cutting balloon, rotational atherectomy, directional coronary atherectomy, and intravascular ultrasound, which were not compatible with 4-Fr catheter.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: 6-Fr TRI (transradial coronary intervention)<br>TRI will be performed using a 6-Fr guiding catheter. | Procedure: PCI (percutaneous coronary intervention)<br>* PCI will be performed via the radial artery.<br>|
| Active Comparator: 4-Fr TRI<br>TRI will be performed using a 4-Fr guiding catheter. | Procedure: PCI (percutaneous coronary intervention)<br>* PCI will be performed via the radial artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Radial Artery Occlusion | The primary endpoint was radial artery occlusion the day after TRI, defined as the absence of a radial pulse confirmed by a reverse Allen's test. | within 2 days after TRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Successful PCI | Procedural success was defined as a postprocedural residual stenosis of less than 20%, and a thrombolysis in myocardial infarction (TIMI) grade 3 angiographic flow without MACE during in-hospital follow-up. | within 2 days after TRI | 
| Number of Patients With Measure Adverse Cardiac Event (MACE) | Defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization | within 2 days after TRI | 
| Number of Patients With Access-site Complications | Access-site-related complications were defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery, which were considered to be major if they were associated with a vascular repair or a blood transfusion. | within 2 days after TRI | 
| Fluoroscopy Time Used for the Procedure | Fluoroscopy time used for the procedure (minutes). | At the end of TRI | 
| Contrast Dye Volume Used for the Procedure | Contrast dye volume used for the procedure (mL). | At the end of TRI | 
| Time Used for the Procedure | Time used for the procedure (minutes). | At the end of TRI | 
| Time Used for Hemostasis | Time Used for Hemostasis (minutes). | within 2 days afterTRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radial artery, transradial intervention, stent