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| Name | Class |
|---|---|
| Mediolanum Cardio Research | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XLIMUS DES | Experimental | Xlimus DES Implantation during coronary angioplasty |
|
| Synergy DES | Active Comparator | Synergy DES Implantation during coronary angioplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xlimus DES Implantation during coronary angioplasty | Device | Xlimus DES Implantation during coronary angioplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal area | Neointimal area calculated at the site of minimal lumen area measured with OCT | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luca Testa, MD | IRCCS Policlinico S. Donato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico S. Donato | San Donato Milanese | Milano | 20097 | Italy | ||
| Hospital Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37745092 | Background | Testa L, Squillace M, Ventrella N, Moreno R, Jimenez-Valero S, Serra A, Gomez Hospital JA, Bellamoli M, Popolo Rubbio A, Bedogni F. A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial. Front Cardiovasc Med. 2023 Sep 6;10:1199475. doi: 10.3389/fcvm.2023.1199475. eCollection 2023. | |
| 31061876 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Randomized multi-centre controlled trial
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The members of the Event Adjudication Committee and the Core Lab will be blinded to the patient assignment.
| Synergy DES Implantation during coronary angioplasty | Device | Synergy DES Implantation during coronary angioplasty |
|
| 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 | 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 | 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 | 12-months follow-up |
| Number of Stent thrombosis | This is defined according to classification proposed by the Academic Research Consortium | 12-months follow-up |
| Percentage of Device success at 24 hours | deployment of the assigned stents without system failure or device-related complication | 24 hours |
| Percentage of Lesion success at 24 hours | attainment of <50% residual stenosis of the target lesion using post-PCI | 24 hours |
| Percentage of Procedural success at 24 hours | lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay | 24 hours |
| Barcelona |
| 08025 |
| Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Testa L, Pero G, Bollati M, Casenghi M, Popolo Rubbio A, Cuman M, Moreno R, Serra A, Gomez JA, Bedogni F. XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial. Int J Cardiol Heart Vasc. 2019 Apr 28;23:100363. doi: 10.1016/j.ijcha.2019.100363. eCollection 2019 Jun. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |