Documented Silent Ischemia, Stable Angina, Unstable Angina
Conditions
Brief summary
The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.
Interventions
DEVICEDES Limus Carbostent
DES Limus Carbostent Carbofilm Coated Coronary Stent
DEVICETaxus Liberté Stent
Taxus Liberté Coronary Stent
Sponsors
CID - Carbostent & Implantable Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patient is eligible for percutaneous coronary intervention (PCI) and for surgical revascularization (CABG) * Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site * Patients with clinical evidence of ischemic heart disease and/or a positive functional study(e.g. stress test); documented stable (CCS I-IV) or unstable angina pectoris (Braunwald class I-II B and C) or documented silent ischemia * LVEF\>30% * Requires treatment of a single de novo lesion in a native coronary artery in one or two different major epicardial vessels (LAD, LCX or RCA). The second lesion must fit with inclusion/
Exclusion criteria
and must be treated with the same study stent as the first lesion * Target lesion should be located in a target vessel with a diameter ranging from 3.0 to 3.75 mm * Target lesion diameter stenosis \> 50% and \< 100% by visual estimate, with a TIMI flow of ≥ 1 * The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm). Any occurred dissection of the target vessel must be treated with an additional stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm) * Patient that underwent BMS implantation more than 6 months before the enrolment or DES implantation more than 1 year before the enrolment in an other vessel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| angiographic efficacy measurement (mm) | 180 days | in-stent Late Lumen Loss (LLL) measurement by angiography |
Secondary
| Measure | Time frame |
|---|---|
| IVUS measurements | 180 days |
| Incidence of cardiac death (%) | 30 days, 180 days, 1, 2 , 3, 4 and 5 years |
| Stent Thrombosis | acute, 30 days, 180 days, 1 year, > 1 year |
| Acute success (Device and Procedural success) | acute |
| QCA measurements in-stent and in-segment | 180 days |
| Incidence of clinically indicated TLR (%) | 30 days, 180 days, 1, 2, 3, 4, 5 years |
| Incidence of all deaths (%) | 30 days, 180 days, 1, 2, 3, 4, 5 years |
| Incidence of all repeat revascularization (%) | 30 days, 180 days, 1, 2, 3, 4, 5 years |
| Incidence of Myocardial Infarction (%) | 30 days, 180 days, 1, 2, 3, 4, 5 years |
Countries
Belgium, France, Germany, Italy
Outcome results
None listed