coronary artery desease stenosis
Conditions
Interventions
None listed
Sponsors
CID S.p.A.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age > 18 years; • Patients with symptoms of stable angina or documented silent ischemia; • Patient with coronary artery disease ranging between 0 and 22 according to the Syntax score; • Patients with acute coronary syndrome, including unstable angina, NSTEMI and STEMI; • Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG); • Left ventricular ejection fraction > 30%; • Target de-novo lesions with diameter stenosis > 50% (including total occlusion); • Target lesion located in a target vessel with a diameter ranging from 2.5 to 4.0 mm; • 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.
Exclusion criteria
Exclusion criteria: • Female with childbearing potential or lactating; • Known allergies to antiplatelets, anticoagulants, contrast media, sirolimus or cobalt chromium; • Acute or chronic renal dysfunction (defined as creatinine greater than 2.5 mg/dl or on dialysis); • Thrombocytopenia (platelet count less than 100,000/mm³) or hypercoagulable disorder; • Known significant gastro-intestinal or urinary bleeding within the past 6 months; • Patient refusing blood transfusion; • Patient currently under immunosuppressant therapy; • Patient with planned surgery within 6 months from the index procedure unless dual antiplatelet therapy is maintained throughout the peri-surgical period; • 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 target vessel revascularization with a DES within 3 months prior to the index procedure; • Target lesion is located or supplied by an arterial or venous bypass graft.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinical composite endpoint at 6 months: Cardiac death / Target vessel MI / Clinically indicated TLR* *Device oriented composite endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of clinical composite endpoints at 30 days, 1 year and yearly up to 5 years from the index procedure: - Cardiac death / Target vessel MI / Clinically indicated TLR* - All death / All MI / All Repeat Revascularization ** *Device oriented composite endpoint **Patient oriented composite endpoint - Incidence of stent thrombosis throughout the study duration, classified according to ARC definition; - Angiographic measurements in-stent and in-segment (reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss) pre and post intervention and at 6-month follow-up, in the first 100 patients included in the pre-specified diabetic subgroup | — |
Countries
Netherlands
Outcome results
None listed