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Aim of this study is to compare at 6 months follow-up, endothelization and malapposition, evaluated by means of optical coherence tomography, in terms of number of struts not endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience.
This is a randomized study aimed at evaluating in 60 patients with either acute coronary syndromes or stable coronary artery disease submitted with PCI and stenting, endothelization and malapposition at 6 months follow-up (primary endpoint), evaluated by means of optical coherence tomography in terms of number of struts not re-endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience. Further clinical follow-up will be performed to evaluate MACE at 12 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRE8 stent | Active Comparator | Treatment with CRE8 stent implantation and evaluated with optical coherence tomography at 6 months |
|
| Biomatrix stent | Active Comparator | Treatment with Biomatrix stent implantation and evaluated with optical coherence tomography at 6 months |
|
| patients treated with Xience stent | Active Comparator | Treatment with Xience stent implantation and evaluated with optical coherence tomography at 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| optical coherence tomography at 6 months | Device | 6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography |
|
| Measure | Description | Time Frame |
|---|---|---|
| stent struts coverage assessed by means of intracoronary optical coherence tomography | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization) | 12 months | |
| inducible ischemia at myocardial scintigraphy | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Giglioli, MD | Azienda Ospedaliero-Universitaria Careggi, Florence, Italy | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31667661 | Derived | Giglioli C, Formentini C, Romano SM, Cecchi E, Baldereschi GJ, Landi D, Chiostri M, Prati F, Marchionni N. Vulnerable struts with CRE8, Biomatrix and Xience stents assessed with OCT and their correlation with clinical variables at 6-month follow-up: the CREBX-OCT study. Int J Cardiovasc Imaging. 2020 Feb;36(2):217-230. doi: 10.1007/s10554-019-01719-1. Epub 2019 Oct 30. |
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To date a decision has not been taken with regard to a possible plan to share data
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