TransRadial Ultra Support Technique (TRUST)

Study Overview
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Brief Summary
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Adequate support is required for challenging percutaneous coronary interventions (PCI). The TransRadial Ultra Support Technique (TRUST technique) is a new support technique that provides active support by deep pass of the coronary wire into the heart cavities (left ventricle-LV, right ventricle-RV) or aorta.

Official Title
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TransRadial Ultra Support Technique (TRUST Technique) Versus Anchoring Technique to Enhance Guiding Catheter Support: a Prospective Randomized Pilot Study

Conditions
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Coronary Arterioscleroses, Coronary Artery Disease

Intervention / Treatment
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* Procedure: TRUST technique
* Procedure: Anchoring Technique
* Procedure: Coronary stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects singed informed consent form Subjects eligible for percutaneous coronary intervention Exclusion Criteria: Age <18 years or >75 years Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3. Known non-adherence to double anti-platelet therapy (DAPT) LVEF <30% Continuing bleeding Acute coronary syndrome (ST-elevation Myocardial infarction) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: TRUST technique + Coronary Stenting<br>PCI with coronary stenting using TransRadial Ultra Support technique for support improvement | Procedure: TRUST technique<br>* A soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily<br>Procedure: Coronary stenting<br>* A standard endovascular procedure of percutaneous coronary intervention with coronary stenting<br>|
| Active Comparator: Anchoring technique + Coronary Stenting<br>PCI with coronary stenting using Wire Anchoring Pass technique for support improvement | Procedure: Anchoring Technique<br>* A standard endovascular technique of coronary wire support improvement<br>Procedure: Coronary stenting<br>* A standard endovascular procedure of percutaneous coronary intervention with coronary stenting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Device success without the occurrence of in-hospital MACCE | 1 week after PCI | 
| Device success | Achievement of a final residual diameter stenosis <20% and a TIMI 3 flow in the target vessel | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, Coronary Artery Disease, Wire, Coronary stenting