CompletedNCT00165035Updated Aug 4, 2011

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

A Phase 3 interventional study of CoStar Paclitaxel Drug Eluting Coronary Stent System and TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent in Coronary Disease, sponsored by Cordis Corporation. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-08-04.

Sponsored by Cordis Corporation · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,701
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Coronary Disease

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Coronary Disease 2,839

Keywords

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

In context

Coronary Disease

2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.

This study's enrollment of 1,701 is above the median of 124 across 1,583 interventional studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 1,701 participants (actual)

Study arms

Experimental
1
CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES
Device: CoStar Paclitaxel Drug Eluting Coronary Stent System
Active comparator
2
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Interventions

DeviceCoStar Paclitaxel Drug Eluting Coronary Stent System
Drug eluting stent
DeviceTAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Drug eluting stent

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

2 sites

Duke University Medical Center
Durham, North Carolina 27705, United States
Christ Linder
Cincinatti, Ohio 45219, United States

References and documents

Publications

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. PubMed 18599890 ↗
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. PubMed 18420096 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 4, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00165035
Lead sponsor: Cordis Corporation
Collaborators: Conor Medsystems
First posted: Sep 14, 2005
Start date: May 2005
Primary completion: Jan 2007
Completion: Jul 2011
Last update: Aug 4, 2011

Study contacts

Dean J Kereiakes, MD

principal investigator · The Christ Hospital, Cincinnati, Ohio

Mitchell W Krucoff, MD

principal investigator · Duke University Medical Center, Durham, NC

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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