Overview

This trial is active, not recruiting.

Conditions stable angina, unstable angina, documented silent ischemia
Treatments des limus carbostent, taxus liberté stent
Phase phase 3
Sponsor CID - Carbostent & Implantable Devices
Start date October 2009
End date April 2011
Trial size 323 participants
Trial identifier NCT01373502, C20902

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
des limus carbostent
DES Limus Carbostent Carbofilm Coated Coronary Stent
(Active Comparator)
taxus liberté stent
Taxus Liberté Coronary Stent

Primary Outcomes

Measure
angiographic efficacy measurement (mm)
time frame: 180 days

Secondary Outcomes

Measure
QCA measurements in-stent and in-segment
time frame: 180 days
IVUS measurements
time frame: 180 days
Incidence of cardiac death (%)
time frame: 30 days, 180 days, 1, 2 , 3, 4 and 5 years
Stent Thrombosis
time frame: acute, 30 days, 180 days, 1 year, > 1 year
Acute success (Device and Procedural success)
time frame: acute
Incidence of Myocardial Infarction (%)
time frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of clinically indicated TLR (%)
time frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of all deaths (%)
time frame: 30 days, 180 days, 1, 2, 3, 4, 5 years
Incidence of all repeat revascularization (%)
time frame: 30 days, 180 days, 1, 2, 3, 4, 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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. Exclusion Criteria: - Female with childbearing potential or lactating - Known sensitivity to sirolimus, paclitaxel, the polymeric matrix, stainless steel or cobalt chromium - Acute Q-wave or non Q-wave myocardial infarction within 72 hours, or presents with CK elevation greater than 2 times upper limit normal associated with elevated CK-MB - Cardiogenic shock - Cerebrovascular accident within the past 6 months - Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl) - Contraindication to aspirin or clopidogrel - Thrombocytopenia (platelet count less than 100,000/mm³) - Active gastrointestinal bleeding within the past 3 months - Known bleeding or hypercoagulable disorder - Prior anaphylactic reaction to contrast agents or contrast sensitivity that cannot be controlled with pre-medication - Currently under immunosuppressant therapy - Currently, or has been treated with either Rapamune or paclitaxel within 12 months of the procedure - Active infection - Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year; - Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study - Patient underwent coronary revascularization to any vessel within 30 days - Patient underwent target vessel revascularization within 6 months - Target vessel has had prior stent placement - Presence of two lesions located in the same vascular territory (same major epicardial vessel) - Prior coronary brachytherapy - There is a planned target lesion treatment with any technique other than the pre-dilatation balloon angioplasty - Treatment of more than two lesions is required at the time of enrolment, or is planned within 30 days following enrolment - Any planned surgery within 6 months after index procedure - Left main disease greater than 50% diameter stenosis - Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off - Heavily calcified vessel and/or lesion which cannot be successfully predilated - Target lesion is located or supplied by an arterial or venous bypass graft - Ostial target lesion or lesion located within 2 mm of a bifurcation - Target lesion involves a side branch >2.0 mm in diameter with an ostial disease - Target lesion has TIMI 0 flow - Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.

Additional Information

Principal investigator Didier Carrié, Prof
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by CID - Carbostent & Implantable Devices.