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Completed

NCT Number: NCT00569491

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Advanced Cardiac Specialists, Gilbert, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAXUS Express 2™

Device

TAXUS Express™ Paclitaxel-Eluting Coronary Stent System

Primary outcomes

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

    Time frame: 1 year post-implant procedure

Secondary outcomes

  1. Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee

    Time frame: 30 days, 6 months, 2 years post-implant procedure

  2. Rate of target vessel related cardiac events as classified by the Clinical Events Committee

    Time frame: 30 days, 6 months, 1 and 2 years post-implant procedure

  3. Rate of other TAXUS related events

    Time frame: 30 days, 6 months, 1 and 2 years post-implant procedure

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: ARRIVE

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Dec 7, 2007
Registry last updated
Sep 25, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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