Clinical trial NCT00974181: The European Cobalt STent With Antiproliferative for Restenosis Trial (EuroSTAR Trial)
Official title: The European Cobalt STent With Antiproliferative for Restenosis Trial (EuroSTAR Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Treatment of Symptomatic Ischemic Heart Disease
Lead sponsor: Cordis Corporation
Sponsor class: INDUSTRY
Collaborators: name: Conor Medsystems
First posted: 2009-09-10
Enrollment: 282
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: 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.

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.

Eligibility criteria: Inclusion Criteria:

All subjects admitted for PCI should be screened for study eligibility.

The subject must meet the following criteria for inclusion into the Study:

1. Subject is ≥ 18-80 years of age,
2. 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,
3. Subject is willing and able to return for the clinical and angiographic follow up,
4. Subject is an acceptable candidate for planned PCI,
5. Subject has stable or unstable angina pectoris (CCS Classification I or greater), or a positive functional study for ischemia,
6. 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
7. 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:
8. The target lesion is a de-novo lesion in a native coronary artery that has not been treated with any previous interventional procedure,
9. The target lesion meets the following angiographic criteria by visual assessment of the Investigator:

   1. The target lesion stenosis must be between 50-99%,
   2. The target reference vessel diameter is between 2.5 mm and 3.5mm,
   3. The lesion length is ≤25 mm, and
   4. Target vessel Thrombolysis in Myocardial Infarction (TIMI) flow must be grade 1 or higher.

Exclusion Criteria:

1. Subject has a left ventricular ejection fraction of \<30%,
2. Subject has an imminent co-morbid illness (i.e., life expectancy less than 2 years),
3. 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,
4. Subject has a known allergy or hypersensitivity to cobalt steel, contrast medium, heparin, or aspirin,
5. Subject has a history of an allergic reaction of hypersensitivity to paclitaxel or drugs in a similar class,
6. Subject is contraindicated for or unwilling to take aspirin and clopidogrel or ticlopidine,
7. Subject has known peptic ulcer with recent (\<3 months GI bleeding,
8. Subject has had a cerebrovascular event (CVA) or transient ischemic attack (TIA) within the prior 6 months,
9. Subject has renal failure defined as a serum creatinine level \>2.5 mg/dL,
10. Subject is in cardiogenic shock,
11. Subject has unstable ventricular arrhythmia,
12. Subject is currently enrolled in another investigational drug or device trial,
13. Subject has undergone PCI or CABG surgery within 30 days of the procedure, and
14. 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:
15. More than 2 lesions required treatment at the time of the procedure
16. Presence of intraluminal thrombus in the target vessel
17. The target lesion involved a bifurcation where the adjacent vessel was greater than 2 mm in diameter requiring intervention
18. 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).

Primary outcomes:
measure: Primary Endpoint Angiographic late loss at 6 months as measured by Quantitative Coronary Analysis (QCA)
timeFrame: 6 months post-procedure
Secondary outcomes:
measure: Endpoints are binary angiographic restenosis and vessel diameter stenosis measured by QCA
timeFrame: 30 days, 6 months, and 12 months post-procedure
measure: Clinical endpoints include device, lesion, and procedural success rates associated with implantation procedure
timeFrame: 30 days, 6 months, and 12 months post-procedure
measure: Safety endpoint consists of composite of major adverse cardiac events
timeFrame: 30 days, 6 months, 1, 2, 3, 4 and 5 year post-procedure
Other outcomes:
Locations:
city: Milan
country: Italy
facility: EMO Centro Cuore Columbus
Study officials:
affiliation: EMO Centro Cuore Columbus
name: Antonio Colombo, MD
role: PRINCIPAL_INVESTIGATOR
References: