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The aim of this study is to evaluate safety and efficacy performances of CRE8 Drug Eluting Stent, in patients comparable to the everyday's clinical practice population, with a specific focus on diabetics, that will be part of a pre-specified study subgroup.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphilimus eluting stent (Cre8) | Experimental | Sirolimus formulated coronary eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphilimus Eluting Stent (CRE8) | Device | Sirolimus formulated coronary eluting stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical composite endpoint: Cardiac death/Target vessel MI/Clinically indicated TLR | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical composite endpoints: - Cardiac death/Target vessel MI/Clinically indicated TLR - All death/All MI/All Repeat Revascularization | At 30 days, 1 year and yearly up to 5 years | |
| Stent thrombosis | within 24 hours, 1 month, 6 months, 1 year and yearly up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Colombo, MD | Fondazione San Raffaele del Monte Tabor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria | |||
| Ziekenhuis Oost Limburg |
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| Angiographic in-stent and in-segment endpoints (in the first 100 patients included in the pre-specified diabetic subgroup). | reference vessel diameter; minimal lumen diameter; % diameter stenosis; binary restenosis; late lumen loss | At 6 months |
| Genk |
| 3600 |
| Belgium |
| Azienda USL 8 Arezzo - Ospedale San Donato | Arezzo | AR | 52100 | Italy |
| A.S.L. CN1 - Ospedale SS Annunziata di Savigliano | Savigliano | CN | 12038 | Italy |
| Istituto Clinico Città Studi | Milan | MI | 20131 | Italy |
| Fondazione San Raffaele del Monte Tabor | Milan | MI | 20132 | Italy |
| Centro Cardiologico Monzino | Milan | MI | 20138 | Italy |
| Istituto Clinico Humanitas IRCCS | Rozzano | MI | 20089 | Italy |
| Azienda di Rilievo Nazionale e di Alta Specializzazione - Presidio Ospedaliero "Civico e Benfratelli" | Palermo | PA | 90127 | Italy |
| Azienda Ospedaliera di Padova | Padova | PD | 35128 | Italy |
| Azienda Ospedaliera S. Salvatore | Pesaro | PU | 61100 | Italy |
| Azienda Policlinico Umberto I | Roma | RM | 00161 | Italy |
| Azienda Sanitaria Locale n°2 Savonese - Ospedale San Paolo | Savona | SV | 17100 | Italy |
| ASL TO2 Torino Nord - Ospedale S. Giovanni Bosco | Torino | TO | 10154 | Italy |
| Clinica Mediterranea SpA | Naples | 80122 | Italy |
| Azienda Ospedaliera Universitaria "Federico II" | Naples | 80131 | Italy |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | 1091 AC | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435CM | Netherlands |
| TweeSteden Ziekenhuis | Tilburg | 5042 AD | Netherlands |
| Oslo University Hospital - Rikshospitalet | Oslo | 0027 | Norway |
| Klinika Kardiologii SPSK4 w Lublinie | Lublin | 20-954 | Poland |
| Szpital Kliniczny Przemienienia Panskiego | Poznan | 61-848 | Poland |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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