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

Cordis

Status and phase: Completed; Phase 3

Conditions: Coronary Disease

Treatments: Device: CoStar Paclitaxel Drug Eluting Coronary Stent System; Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00165035

COSTAR II

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,701 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 Exclusion Criteria:

• Known sensitivity to paclitaxel or polymeric matrices: Translute or PLGA.
• Planned treatment with any other PCI device in the target vessel(s).
• MI within 72 hours prior to the index procedure
• Patient is in cardiogenic shock
• Cerebrovascular Accident (CVA) within the past 6 months
• Acute or chronic renal dysfunction (creatinine >2.0 mg/dl or >150 µmol/L)
• Contraindication to ASA or to clopidogrel
• Thrombocytopenia
• Active GI bleeding within past three months
• Known allergy to stainless steel or cobalt chromium
• Any prior true anaphylactic reaction to contrast agents
• Patient is currently taking colchicine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,701 participants in 2 patient groups

1

Experimental group

Description:

CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES

Treatment:

Device: CoStar Paclitaxel Drug Eluting Coronary Stent System

2

Active Comparator group

Description:

TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Treatment:

Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent