TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Boston Scientific

Status and phase

Completed

Phase 4

Conditions

de Novo Coronary Lesions

Cardiovascular Disease

Treatments

Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00569751

S2200

Details and patient eligibility

About

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.

Enrollment

5,016 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.