An interventional study of device implantation during coronary angioplasty in Coronary Artery Disease and Diabetes, sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS. Completed at 6 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS · Not applicable, Interventional, and Treatment
The objective of the study is to compare angiographic and clinical performance of Abluminus DES+ versus Everolimus-eluting DES in patients with diabetes mellitus.
The present clinical investigation is designed as a prospective, multicentre, national, randomized, open label, 2-arm parallel group, pilot trial comparing Abluminus DES+ versus Everolimus-eluting DES on Late Lumen Loss and clinical outcomes in diabetic patients undergoing Percutaneous Coronary Intervention.
A total of 165 patients will be recruited and randomized in the two groups in a 2:1 ratio at up to 6-8 Italian sites.
After index procedure, patients will be followed up by angiographic follow-up at 9 months and clinical follow-up at 12 months.
The study design is open label, since it is not possible to blind the investigators as to the stent type. However the members of the Event Adjudication Committee will be blinded to the patient. assignment. All medical records, source documentation and event information collected for the adjudication process will be blinded to treatment assignment.
In addition the primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment.
Exclusion Criteria:
device implantation during coronary angioplasty
Device: device implantation during coronary angioplasty
device implantation during coronary angioplasty
Device: device implantation during coronary angioplasty
device implantation during coronary angioplasty
In-stent neointimal volume
In-stent neointimal volume, measured with OCT, following PCI with Abluminus DES+ compared with in-stent neointimal volume following PCI with Everolimus-eluting DES.
Time frame: 9-month follow-up
Neointimal area
Neointimal area, calculated at the site of minimal lumen area measured with OCT.
Time frame: 9-month follow-up
Target Lesion Failure
This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR
Time frame: 12 months
Stent thrombosis
This is defined according to classification proposed by the Academic Research Consortium
Time frame: 12 months
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
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 cause33 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
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.
Time frame: 12 months
Device success at 24 hours
deployment of the assigned stents without system failure or device-related complication
Time frame: 24 hours
Lesion success
Attainment of \<50% residual stenosis of the target lesion using post-PCI
Time frame: 24 hours
Procedural success
Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay
Time frame: 24 hours
Plan to share: No
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS