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Treatment of Symptomatic Ischemic Heart DiseasePhase 3NCT00974181

The European Cobalt STent With Antiproliferative for Restenosis Trial (EuroSTAR Trial)

A Phase 3 study testing Conor Medsystems COSTAR™ stent (10 µg Paclitaxel) and Conor Medsystems COSTAR™ stent (30 µg Paclitaxel) in people with Treatment of Symptomatic Ischemic Heart Disease, run by Cordis US Corp. at 1 site in Italy.

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

Two consecutive cohorts of subjects were each treated with the CoStar stent loaded with a different paclitaxel dose regimen. The first 145 subjects (Arm I), enrolled between 20 January 2004 and 26 May 2004, were treated with 10 µg paclitaxel and the subsequent 137 subjects (Arm II), enrolled between 15 December 2004… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Conor Medsystems COSTAR™ stent (10 µg Paclitaxel) and Conor Medsystems COSTAR™ stent (30 µg Paclitaxel)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
282 participants
Where
1 siteItaly
Study dates
Jan 2004to Mar 2010
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

  • All subjects admitted for PCI should be screened for study eligibility.
  • The subject must meet the following criteria for inclusion into the Study:
  • Subject is ≥ 18-80 years of age,
  • Subject understands the risks, benefits and alternatives to Percutaneous Coronary Intervention (PCI) and has signed the Informed Consent as approved by the Institution for the implantation of the COSTAR™ stent,
  • Subject is willing and able to return for the clinical and angiographic follow up,
  • Subject is an acceptable candidate for planned PCI,
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  • Subject has stable or unstable angina pectoris (CCS Classification I or greater), or a positive functional study for ischemia,
  • Subject is male, or female subject is post-menopausal or of non-child bearing potential, and/or has a negative pregnancy test at the time of PCI, and
  • No other treatments are planned within 30 days of the procedure.
  • Up to two lesions may be treated using the COSTAR™ stent per study subject, either two discreet lesions in one vessel separated by > 20mm or two discreet lesions in two native coronary arteries. Upon coronary angiography at the time of PCI, each lesion under consideration for treatment must meet the following angiographic criteria for inclusion into the study:
  • The target lesion is a de-novo lesion in a native coronary artery that has not been treated with any previous interventional procedure,
  • The target lesion meets the following angiographic criteria by visual assessment of the Investigator:
  • The target lesion stenosis must be between 50-99%,
  • The target reference vessel diameter is between 2.5 mm and 3.5mm,
  • The lesion length is ≤25 mm, and
  • Target vessel Thrombolysis in Myocardial Infarction (TIMI) flow must be grade 1 or higher.

Who cannot join

  • Subject has a left ventricular ejection fraction of <30%,
  • Subject has an imminent co-morbid illness (i.e., life expectancy less than 2 years),
  • Subject has experienced an acute myocardial infarction (MI) 72 hours prior to the procedure, as defined either by the presence of a new Q wave in 2 or more contiguous leads, or by a CK greater than two times site upper limit normal value with presence of CKMB greater than the site upper limit normal value,
  • Subject has a known allergy or hypersensitivity to cobalt steel, contrast medium, heparin, or aspirin,
  • Subject has a history of an allergic reaction of hypersensitivity to paclitaxel or drugs in a similar class,
  • Subject is contraindicated for or unwilling to take aspirin and clopidogrel or ticlopidine,
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  • Subject has known peptic ulcer with recent (<3 months GI bleeding,
  • Subject has had a cerebrovascular event (CVA) or transient ischemic attack (TIA) within the prior 6 months,
  • Subject has renal failure defined as a serum creatinine level >2.5 mg/dL,
  • Subject is in cardiogenic shock,
  • Subject has unstable ventricular arrhythmia,
  • Subject is currently enrolled in another investigational drug or device trial,
  • Subject has undergone PCI or CABG surgery within 30 days of the procedure, and
  • Subject is unable to comply with the follow up requirements, or would be unreliable for follow up documentation.
  • Upon coronary angiography at the time of PCI, the lesion was excluded from the study if any of the following angiographic criteria were met:
  • More than 2 lesions required treatment at the time of the procedure
  • Presence of intraluminal thrombus in the target vessel
  • The target lesion involved a bifurcation where the adjacent vessel was greater than 2 mm in diameter requiring intervention
  • Patient had an evolving myocardial infarction as evidenced by persistent new ECG changes during PCI (defined as new ST segment elevation or depression of > 1.0 mm for > 30 min).

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • EMO Centro Cuore Columbus

    Milan

Other trials in Italy

About this study

Two consecutive cohorts of subjects were each treated with the CoStar stent loaded with a different paclitaxel dose regimen. The first 145 subjects (Arm I), enrolled between 20 January 2004 and 26 May 2004, were treated with 10 µg paclitaxel and the subsequent 137 subjects (Arm II), enrolled between 15 December 2004 and 9 March 2005, were treated with 30 µg paclitaxel. Both dose formulations eluted over 30 days (in-vitro).

Subjects in both arms completed clinical follow-up at 1, 6 and 12 months post-index procedure, with angiographic follow-up at 6 months as outlined in the original study protocol.

Based on results from previous studies and the initial EuroSTAR Trial results, Conor Medsystems decided to pursue the dosage used in Arm I, 10 μg/30 days, as the commercial dose formulation for the CoStar® stent. The EuroSTAR Trial addendum was proposed for the purpose of evaluating the long-term clinical outcomes of the CoStar stent.

Read the detailed description

The EuroSTAR Trial (European Cobalt STent with Antiproliferative for Restenosis Trial) is a prospective, multi-center, two-arm study to evaluate the safety and performance of the CoStar® stent for the treatment of symptomatic ischemic heart disease attributable to stenotic de novo lesions of the native coronary arteries that are amenable to treatment by percutaneous stenting.

Being tested
Conor Medsystems COSTAR™ stent (10 µg Paclitaxel), Conor Medsystems COSTAR™ stent (30 µg Paclitaxel)

What participants receive

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

  • Conor Medsystems COSTAR™ stent (10 µg Paclitaxel)Device

    Intervention will consist of percutaneous coronary intervention for treatment of one or more de-novo coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the CoStar™ Paclitaxel-Eluting Coronary Stent System (10 µg Paclitaxel)

  • Conor Medsystems COSTAR™ stent (30 µg Paclitaxel)Device

    Intervention will consist of percutaneous coronary intervention for treatment of one or more de-novo coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the CoStar™ Paclitaxel-Eluting Coronary Stent System (30 µg Paclitaxel)

Study groups in NCT00974181
Study groupRoleWhat they receive
Conor Medsystems COSTAR™ stent (10 µg Paclitaxel)Active comparatorConor Medsystems COSTAR™ stent loaded with the antiproliferative compound paclitaxel (10 µg), pre-mounted on a rapid exchange, percutaneous transluminal coronary angioplasty balloon catheter.
Receives: Device: Conor Medsystems COSTAR™ stent (10 µg Paclitaxel)
Conor Medsystems COSTAR™ stent (30 µg Paclitaxel)Active comparatorConor Medsystems COSTAR™ stent loaded with the antiproliferative compound paclitaxel (30 µg), pre-mounted on a rapid exchange, percutaneous transluminal coronary angioplasty balloon catheter.
Receives: Device: Conor Medsystems COSTAR™ stent (30 µg Paclitaxel)

What is being measured

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

  1. Primary Endpoint Angiographic late loss at 6 months as measured by Quantitative Coronary Analysis (QCA)

    Measured: 6 months post-procedure

Secondary outcomes (3)

  1. Endpoints are binary angiographic restenosis and vessel diameter stenosis measured by QCA

    Measured: 30 days, 6 months, and 12 months post-procedure

  2. Clinical endpoints include device, lesion, and procedural success rates associated with implantation procedure

    Measured: 30 days, 6 months, and 12 months post-procedure

  3. Safety endpoint consists of composite of major adverse cardiac events

    Measured: 30 days, 6 months, 1, 2, 3, 4 and 5 year post-procedure

Timeline

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

  1. First posted10 Sep 2009 (estimated)
  2. Study startJan 2004
  3. Primary completionMay 2005
  4. Study completionMar 2010

Resources

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
None (open label)
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974181
Sponsor's protocol ID
EUS08
Other IDs
EUROSTAR
Status last verified
May 2010
First submitted
9 Sep 2009
Last updated
17 May 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conor Medsystems COSTAR™ stent (10 µg Paclitaxel) and Conor Medsystems COSTAR™ stent (30 µg Paclitaxel) in people with Treatment of Symptomatic Ischemic Heart Disease, run by Cordis US Corp. at 1 site in Italy.

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 16 inclusion and 19 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 17 May 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

Primary Endpoint Angiographic late loss at 6 months as measured by Quantitative Coronary Analysis (QCA) (time frame: 6 months post-procedure). 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 NCT00974181.

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 17 May 2010.

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