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| Name | Class |
|---|---|
| Mediolanum Cardio Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABLUMINUS DES+ | Experimental | device implantation during coronary angioplasty |
|
| Everolimus-eluting DES | Active Comparator | device implantation during coronary angioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| device implantation during coronary angioplasty | Device | device implantation during coronary angioplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal area | Neointimal area, calculated at the site of minimal lumen area measured with OCT. | 9-month follow-up |
| Target Lesion Failure | This will be a composite of cardiac death, target-vessel MI, and clinically indicated TLR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Colombo, MD | Ospedale San Raffaele | Study Director |
| Azeem Latib, MD | Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Miano | Milano | 20132 | Italy | ||
| Ospedale Humanitas |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized multi-centre controlled clinical trial
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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
| 12 months |
| Stent thrombosis | This is defined according to classification proposed by the Academic Research Consortium | 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. | 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 | 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. | 12 months |
| Device success at 24 hours | deployment of the assigned stents without system failure or device-related complication | 24 hours |
| Lesion success | Attainment of <50% residual stenosis of the target lesion using post-PCI | 24 hours |
| Procedural success | Lesion success without the occurrence of Major Adverse Cardiac Events during the hospital stay | 24 hours |
| Rozzano |
| Milano |
| 20089 |
| Italy |
| Policlinico San Donato | San Donato Milanese | Milano | 20097 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Federico II | Naples | 20131 | Italy |
| Policlinico S. Matteo | Pavia | 27100 | Italy |
| Ospedale San Pietro, Fatebenefratelli | Roma | 00189 | Italy |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |