Coronary Artery Disease
Conditions
Brief summary
The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty
Detailed description
The present clinical investigation is designed as a prospective, multicentre, international, randomized, open label, 2-arm parallel group, trial in patients undergoing Percutaneous Coronary Intervention (PCI) comparing Xlimus DES versus Synergy DES with respect to optical coherence tomography (OCT) derived measures at 6-month Follow Up (FU) and clinical events at 12 months after procedure. A total of 180 patients will be recruited and randomized in the two groups in a 2:1 ratio. After index procedure, patients will be followed up by angiographic follow-up at 6 months and clinical follow-up at 12 months.The primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment
Interventions
DEVICEXlimus DES Implantation during coronary angioplasty
Xlimus DES Implantation during coronary angioplasty
DEVICESynergy DES Implantation during coronary angioplasty
Synergy DES Implantation during coronary angioplasty
Sponsors
Mediolanum Cardio Research
Cardionovum GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The members of the Event Adjudication Committee and the Core Lab will be blinded to the patient assignment.
Intervention model description
Randomized multi-centre controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥18 2. Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI. 3. PCI considered appropriate and feasible 4. Culprit de novo lesion in a native coronary artery with significant stenosis (\>50% by visual estimate) eligible for implantation with either study stent (no limitation on the number of treated lesions, vessel and lesion length); 5. Patient provides written informed consent 6. Patient agrees to all required follow-up procedures and visits. 7. Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm
Exclusion criteria
1. The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus or its derivatives, everolimus or structurally-related compounds, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled); 2. Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum; 3. Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer; 4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study and not using adequate contraceptive methods; 5. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions; 6. Previous coronary intervention on target vessel in the 3-months prior to enrollment; 7. Non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment); 8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period; 9. Previously documented left ventricular ejection fraction (LVEF) \<30%; 10. Evident cardiogenic shock before randomization; 11. Patients with left main stem stenosis (\>50% by visual estimate); 12. In-stent restenosis; 13. ST-segment elevation MI; 14. Chronic total occlusion/ heavily calcified lesions 15. Culprit lesion to a Saphenous Vein graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent neointimal volume | 6-month follow-up | In-stent neointimal volume at 6-month follow-up, measured with OCT, as assessed by the Core-Lab. Neointimal volume will be calculated in all analyzed cross-sections and volumetric measurements and in stent neointimal volume will be compared in the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Target lesion failure | 12-months follow-up | composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR) |
| Number of patients experiencig Cardiac death | 12-months follow-up | Any death due to proximate cardiac cause (eg, MI, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death |
| Number of Target-vessel Myocardial infarction | 12-months follow-up | any MI that, irrespective of the time after the index procedure, is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. Type of acute MI is classified according to the Joint ESC/ACCF/AHA/ WHF Joint Task Force for the Universal Definition of Myocardial Infarction |
| Number of Target-lesion revascularization | 12-months follow-up | repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI |
| Neointimal area | 6-month follow-up | Neointimal area calculated at the site of minimal lumen area measured with OCT |
| Percentage of Device success at 24 hours | 24 hours | deployment of the assigned stents without system failure or device-related complication |
| Percentage of Lesion success at 24 hours | 24 hours | attainment of \<50% residual stenosis of the target lesion using post-PCI |
| Percentage of Procedural success at 24 hours | 24 hours | lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay |
| Number of Stent thrombosis | 12-months follow-up | This is defined according to classification proposed by the Academic Research Consortium |
Countries
Italy, Spain
Outcome results
None listed