TRI-stent Adjudication Study - Low risk of Restenosis

Objectives
The primary objective of this study is to show superiority of the Genous EPC capturing stent compared to a bare metal stent in its capacity to prevent target lesion failure within one year in statin treated patients undergoing a percutaneous intervention of a de novo, coronary artery lesion(s) with a low risk of restenosis.
The secondary objective of this study is show non-inferiority of the Genous EPC capturing stent relative to a bare metal stent with regard to the long-term incidence of (potentially stent thrombosis related) cardiac death or myocardial infarction.
Patient selection
In this European, multi-center, prospective, randomized trial a total of 1260 clinically stable patients with coronary artery lesions with a low risk of restenosis and an indication for elective percutaneous coronary treatment are randomized. A target lesion is considered to be at low risk of restenosis if all of the following apply: (1) A de novo lesion located in a native epicardial vessel with a Reference Vessel Diameter (RVD) greater than 2.8 mm by visual estimation, (2) a de novo lesion with a length of smaller than 20 mm by visual estimation, (3) a de novo lesion with a TIMI flow equal to or greater than 1, (4) the patient does not have diabetes mellitus.
Suitable candidates are either patients with stable exercise-induced angina or patients stabilized after an episode of unstable angina or non-ST elevation myocardial infarction. Furthermore, all patients entered into this trial have lesions suitable for treatment with either study stent. Patients must have been on statin therapy for at least seven days. Patients with coronary artery lesions considered at high risk for restenosis are excluded from this trial.
Randomization and treatment
All included patients are randomly assigned in a 1:1 ratio to the Genous EPC capturing stent or a bare metal stent.
Patients with multiple lesions are eligible if all target lesions are low-risk lesions. The randomized treatment assignment must be followed for all treated lesions. Clopidogrel is started before or during PCI procedure and continued on a daily basis for a minimum of four weeks, irrespectively of the type of stent used. The prescribed statin should be atorvastatin in a dosage of at least 40 mg or other statins in equivalent dosages and should be continued for the duration of the study.
Follow-up
Patients are followed clinically by telephone contact at 30 days, six months, one year, two, three, four and five years following the index stenting procedure.
Scheduling of angiographic evaluation of the treated lesion(s) is at the discretion of the treating physician. Repeat coronary angiography, if performed, is preferably scheduled after twelve months and angiograms should be suitable for off-line quantitative coronary angiography.
Endpoints
The primary efficacy endpoint is target lesion failure within one year, defined as the composite of cardiac death, myocardial infarction (unless documented to unequivocally arise from a non-treated coronary artery) and clinically driven repeat revascularization of any of the treated target lesions.
The main long-term endpoint is defined as cardiac death or myocardial infarction (unless documented to unequivocally arise from a non-treated coronary artery) within five years.
The secondary endpoints are: (1) procedural success, defined as a less than 20% residual stenosis by off-line QCA and TIMI 3 flow post PCI procedure of the treated vessel, (2) target lesion revascularization, (3) target lesion failure, (4) target vessel revascularization, (5) target vessel failure, (6) in-stent late loss, (7) in-segment late loss, (8) stent thrombosis, (9) hospitalization for acute coronary syndrome, (10) cardiac death or myocardial infarction.

In this multi-center, prospective, randomized trial a total of 1260 patients with lesions with a low risk of coronary restenosis and an indication for percutaneous coronary treatment are randomized to evaluate the superiority of the Genous™ EPC capturing stent as compared to a bare metal stent

Elective PCI with stent placement