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The purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRE8 arm | Experimental |
| |
| Vision/Multilik8 arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphilimus Eluting Stent | Device | Sirolimus formulated coronary eluting stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of ≤ 0.3, determined by OCT | 1 month for the BMS arm; 3 months for the DES arm | within 3 months from index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of malapposed stent struts | Immediately post index procedure, 1 month (BMS arm) / 3 months (DES arm) | |
| Percentage of malapposed and uncovered stent struts | 1 month (BMS arm) / 3 months (DES arm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Prati, MD | Ospedale S. Giovanni - Addolorata | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero - Universitaria S.Anna | Ferrara | FE | 44121 | Italy | ||
| Policlinico Universitario "Agostino Gemelli" |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Bare Metal Stent |
| Device |
Bare metal coronary stent |
|
| Neointimal growth and neointimal thickness | 1 month (BMS arm) / 3 months (DES arm) |
| Angiographic in-stent and in-segment endpoints | reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss | immediately pre and post index procedure, 1 month (BMS arm) / 3 months (DES arm) |
| Clinical composite endpoints |
| At 1, 3 and 12 months |
| Stent Thrombosis | during index procedure, immediately after index procedure, 1 month, 3 months, 12 months |
| Roma |
| RM |
| 00168 |
| Italy |
| Azienda Ospedaliera S. Giovanni - Addolorata | Roma | RM | 00184 | Italy |
| Presidio Ospedaliero Umberto I - Azienda Ospedaliera "Ordine Mauriziano di Torino" | Torino | TO | 10128 | Italy |
| ULSS n°3 - Ospedale Civile | Bassano del Grappa | VI | 36061 | Italy |
| University Medical Centre Utrecht | Utrecht | Netherlands |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |