Clinical trial NCT00165035: Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Disease
Keywords: Percutaneous coronary intervention (PCI)
Drug eluting stent (DES)
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: Conor Medsystems
First posted: 2005-09-14
Enrollment: 1701
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death
timeFrame: 8 months
measure: In-segment late lumen loss
timeFrame: 9 months
Secondary outcomes:
measure: Device, lesion and procedure success
timeFrame: At procedure or hospital discharge
measure: Incidence of MACE
timeFrame: 30 days, 9 months and 12 months
measure: Coronary angiography in the angiographic cohort
timeFrame: 9 months
measure: Target lesion revascularization
timeFrame: 8 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinatti
country: United States
facility: Christ Linder
state: Ohio
Study officials:
affiliation: The Christ Hospital, Cincinnati, Ohio
name: Dean J Kereiakes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Center, Durham, NC
name: Mitchell W Krucoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 in the COSTAR II randomized trial. J Invasive Cardiol. 2008 Jul;20(7):335-41.
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 Investigators Group. A novel bioresorbable polymer paclitaxel-eluting stent for the treatment of single and multivessel coronary disease: primary results of the COSTAR (Cobalt Chromium Stent With Antiproliferative for Restenosis) II study. J Am Coll Cardiol. 2008 Apr 22;51(16):1543-52. doi: 10.1016/j.jacc.2008.01.020.