Cardiovascular Disease, de Novo Coronary Lesions
Conditions
Keywords
de novo, coronary, coronary artery disease, coronary disease
Brief summary
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.
Interventions
DEVICETAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System
Drug Eluting Stent used to treat de novo coronary artery lesions.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC). | 1-year post-implant procedure |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed