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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
180
Xlimus DES Implantation during coronary angioplasty
Synergy DES Implantation during coronary angioplasty
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, Italy
Hospital Bellvitge
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital La Paz
Madrid, Spain
In-stent neointimal volume
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.
Time frame: 6-month follow-up
Neointimal area
Neointimal area calculated at the site of minimal lumen area measured with OCT
Time frame: 6-month follow-up
Number of Target lesion failure
composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR)
Time frame: 12-months follow-up
Number of patients experiencig Cardiac death
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
Time frame: 12-months follow-up
Number of Target-vessel Myocardial infarction
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
Time frame: 12-months follow-up
Number of Target-lesion revascularization
repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI
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Time frame: 12-months follow-up
Number of Stent thrombosis
This is defined according to classification proposed by the Academic Research Consortium
Time frame: 12-months follow-up
Percentage of Device success at 24 hours
deployment of the assigned stents without system failure or device-related complication
Time frame: 24 hours
Percentage of Lesion success at 24 hours
attainment of \<50% residual stenosis of the target lesion using post-PCI
Time frame: 24 hours
Percentage of Procedural success at 24 hours
lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay
Time frame: 24 hours