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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165035
• Other study ID #: COSTAR II
• Status: Completed
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: August 3, 2011
• Start date: May 2005
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1701
• Est. completion date: July 2011
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• CoStar Paclitaxel Drug Eluting Coronary Stent System
Drug eluting stent
• TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Drug eluting stent

Locations

Country	Name	City	State
United States	Christ Linder	Cincinatti	Ohio
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Cordis Corporation	Conor Medsystems

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kereiakes DJ, Petersen JL, Batchelor WB, Fitzgerald PJ, Mehran R, Lansky A, Tsujino I, Schofer J, Dubois C, Verheye S, Cristea E, Garg J, Wijns W, Krucoff MW. Clinical and angiographic outcomes in diabetic patients following single or multivessel stenting — View Citation

Krucoff MW, Kereiakes DJ, Petersen JL, Mehran R, Hasselblad V, Lansky AJ, Fitzgerald PJ, Garg J, Turco MA, Simonton CA 3rd, Verheye S, Dubois CL, Gammon R, Batchelor WB, O'Shaughnessy CD, Hermiller JB Jr, Schofer J, Buchbinder M, Wijns W; COSTAR II Invest — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death		8 months	Yes
Primary	In-segment late lumen loss		9 months	No
Secondary	Device, lesion and procedure success		At procedure or hospital discharge	No
Secondary	Incidence of MACE		30 days, 9 months and 12 months	Yes
Secondary	Coronary angiography in the angiographic cohort		9 months	Yes
Secondary	Target lesion revascularization		8 months	No