XIENCE V® EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery

Study Overview
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Brief Summary
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This trial is to assess physician-determined XIENCE V® EECSS acute performance, deliverability and resource utilization in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience

Detailed Description
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This study will evaluate overall physician-determined XIENCE V® Everolimus Eluting Coronary Stent system (XIENCE V®) acute performance, deliverability and resource utilization in the catheterization lab in the real world as used by a broad group of physicians at a variety of health care facilities. This study will include all consecutively enrolled patients in the United States of America (USA) who consent to participate and receive XIENCE V® stents.

Official Title
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XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) EXCEED: Evaluation of XIENCE V® Catheterization Lab Endpoints and Excellence in Delivery

Conditions
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Atherosclerosis, Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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General Inclusion Criteria: The patient agrees to participate in this study by signing the IRB approved informed consent form prior to the index procedure. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form prior to the index procedure. General Exclusion Criteria: Inability to obtain an informed consent is an exclusion criterion.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>The procedures undergone by this group will be evaluated for: Acute performance, deliverability and resource utilization during the procedure in the catheterization lab during commercial use by various physicians with a range of coronary stenting experience. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall physician-determined XIENCE V® EECSS acute performance and deliverability. |  | acute | 
| Physician-determined procedure success |  | acute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual component of adjunctive devices and drugs used during procedure. Number and type of guide wires |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure. Number and type of guiding catheters |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure. Number and type of balloon dilation catheters |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure: Balloon pressures (pre-dilation/post-dilation pressures) |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure: Number of stents |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure: Amount of radiographic contrast |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure: Fluoroscopy time |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure: Duration of PCI procedure |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure: IVUS use |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure: Thienopyridine loading dose (prior to, during or after procedure) |  | acute | 
| Individual component of adjunctive devices and drugs used during procedure: Aspirin loading dose (prior to, during or after procedure) |  | acute | 
| Device Success |  | acute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stent, Percutaneous Coronary Intervention, Everolimus