Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)

Multi-Center, Single-Blind, Two-Arm, Randomized, Controlled, Non Inferiority Trial of the Conor CoStar Paclitaxel-Eluting Coronary Stent System vs the TAXUS DES in Patients With De Novo Lesions of the Native Coronary Arteries

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00165035

Enrollment

1701

Registered

2005-09-14

Start date

2005-05-31

Completion date

2011-07-31

Last updated

2011-08-04

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

Conditions

Coronary Disease

Keywords

Percutaneous coronary intervention (PCI), Drug eluting stent (DES)

Brief summary

The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent) in the treatment of single-vessel (one blood vessel) and multi-vessel (two or three blood vessels) coronary artery disease.

Detailed description

Non -inferiority in 8-month Major Adverse Cardiac Events (MACE) and in-segment late lumen loss at 9 months between the CoStar™ Paclitaxel-Eluting Coronary Stent System and the TAXUS™ Express2™ Drug Eluting Coronary Stent System for the treatment of a single de novo lesion per vessel in patients with single and multi-vessel coronary disease.

Interventions

DEVICECoStar Paclitaxel Drug Eluting Coronary Stent System

Drug eluting stent

DEVICETAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Drug eluting stent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

General Inclusion Criteria: * Eligible for percutaneous coronary intervention (PCI) * Documented stable or unstable angina pectoris (Class I, II, III or IV), documented ischemia, or documented silent ischemia * Documented LVEF ≥25% within the last 6 weeks. * Eligible for coronary artery bypass graft surgery (CABG)

Exclusion criteria

General

Design outcomes

Primary

Measure	Time frame
MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death	8 months
In-segment late lumen loss	9 months

Secondary

Measure	Time frame
Device, lesion and procedure success	At procedure or hospital discharge
Incidence of MACE	30 days, 9 months and 12 months
Coronary angiography in the angiographic cohort	9 months
Target lesion revascularization	8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026