TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Study Overview
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Brief Summary
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The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.

Official Title
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TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Conditions
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Cardiovascular Disease, de Novo Coronary Lesions

Intervention / Treatment
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* Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Appropriate Patient Criteria: Patient is eligible to receive a Boston Scientific TAXUS Stent Inappropriate Patient Criteria: Known sensitivity to paclitaxel. Known allergy to stainless steel. Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. Patients with unresolved vessel thrombus at the lesion site. Patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm. Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation. Patients with diffuse disease or poor overflow distal to the identified lesions. Patients with tortuous vessels in the region of the obstruction or proximal to the lesion. Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System|Drug Eluting Stent used to treat de novo coronary artery lesions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC). |  | 1-year post-implant procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of TAXUS stent related cardiac events as classified by the CEC. |  | within 30 days, 6 months and 2 years | 
| Rate of target vessel related cardiac events as classified by the CEC. |  | 30 days, at 6 months, at 1 and 2 years post-implant procedure | 
| Rate of other TAXUS related events |  | 30 days, 6 months, 1 and 2 years post-implant procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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de novo, coronary, coronary artery disease, coronary disease