Coronary DiseasePhase 3NCT00165035

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

A Phase 3 study testing CoStar Paclitaxel Drug Eluting Coronary Stent System and TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent in people with Coronary Disease, run by Cordis US Corp. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Disease
What is being tested?: CoStar Paclitaxel Drug Eluting Coronary Stent System and TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,701 participants
Where: 2 sitesUnited States
Study dates: May 2005to Jul 2011
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 13Show fewer

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 locations and contacts

2 sites in 1 country.

United States2 sites

Christ Linder
Cincinnati, Ohio, 45219
Duke University Medical Center
Durham, North Carolina, 27705

Other trials in United States

About this study

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

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: Coronary Disease
Being tested: CoStar Paclitaxel Drug Eluting Coronary Stent System, TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
Keywords: Percutaneous coronary intervention (PCI), Drug eluting stent (DES)
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CoStar Paclitaxel Drug Eluting Coronary Stent SystemDevice
Drug eluting stent
TAXUS™ Express2™ Paclitaxel-Eluting Coronary StentDevice
Drug eluting stent

Study groups in NCT00165035
Study group	Role	What they receive
1	Experimental	CoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES Receives: Device: CoStar Paclitaxel Drug Eluting Coronary Stent System
2	Active comparator	TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent Receives: Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2005Jul 2011

First posted14 Sep 2005 (estimated)
Study startMay 2005
Primary completionJan 2007
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,701 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00165035
Sponsor's protocol ID: COSTAR II
Status last verified: Aug 2011
First submitted: 9 Sep 2005
Last updated: 4 Aug 2011
Results posted: No
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00165035
Acronym / sponsor ID: COSTAR II
Conditions: Coronary Disease
Keywords: Percutaneous coronary intervention (PCI), Drug eluting stent (DES)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,701 participants (actual)
Lead sponsor: Cordis US Corp.Industry (pharma, biotech, devices)
Collaborators: Conor Medsystems
Study start: May 2005
Primary completion: Jan 2007 (actual)
Study completion: Jul 2011 (actual)
First posted: 14 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: CoStar Paclitaxel Drug Eluting Coronary Stent SystemCoStar™ Paclitaxel-Eluting Coronary Stent, a reservoir based DES
2	Active comparator	Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary StentTAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CoStar Paclitaxel Drug Eluting Coronary Stent SystemDrug eluting stent	Device	1
TAXUS™ Express2™ Paclitaxel-Eluting Coronary StentDrug eluting stent	Device	2

Primary outcome

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

4 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
Results publication: PubMed 18599890Kereiakes 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.
Results publication: PubMed 18420096Krucoff 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dean J Kereiakes, MD principal investigator

The Christ Hospital, Cincinnati, Ohio

Mitchell W Krucoff, MD principal investigator

Duke University Medical Center, Durham, NC

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE defined as a composite of target vessel revascularization, new myocardial infarction (MI), or cardiac death (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00165035, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2011.