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TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program

TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance Program

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00569491
Acronym
ARRIVE
Enrollment
2585
Registered
2007-12-07
Start date
2004-02-29
Completion date
2007-04-30
Last updated
2008-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

The TAXUS ARRIVE 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 Express 2™

TAXUS Express™ Paclitaxel-Eluting Coronary Stent System

Sponsors

Boston Scientific Corporation
Lead SponsorINDUSTRY

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 Patients 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 \< 2.5 mm or \> 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

MeasureTime frame
Rate of TAXUS stent related cardiac events at a 1-year post implant procedure as classified by the Clinical Events Committee1 year post-implant procedure

Secondary

MeasureTime frame
Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee30 days, 6 months, 2 years post-implant procedure
Rate of target vessel related cardiac events as classified by the Clinical Events Committee30 days, 6 months, 1 and 2 years post-implant procedure
Rate of other TAXUS related events30 days, 6 months, 1 and 2 years post-implant procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026