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Clinical trial with an "European Community marked" medical device in patients with ischemic heart disease and clinical indication of coronary revascularization with drug-eluting stent.
Clinical follow-up will be done according to this way: first month telephone or face-to-face interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography)
A randomized clinical trial to compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.(non-inferiority design)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANGIOLITE | Active Comparator | Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent. |
|
| Xience | Active Comparator | Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiolite | Device | Percutaneous coronary intervention |
| |
| Xience |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy:Measure the late loss (LL) in the follow-up of the Angiolite stent is not different from the late loss of the xience stent (non-inferiority) | Measure the late loss (LL) in the follow-up of the Angiolite stent is not different from the late loss of the xience stent (non-inferiority) | 6 months |
| Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR)) | Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR)) during follow-up for no differences between Angiolite and Xience stents | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Follow up | Compare differences between Angiolite and Xience stent during the follow-up in independent components of the major adverse cardiac events rate: All cause death, any myocardial infarction and any revascularization | 1 year |
| Thrombosis rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Ibares | Cardiva2 S.L. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña | 15706 | Spain | ||
| Hospital de León |
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| Device |
Percutaneous coronary intervention |
|
Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience
| 1 year |
| MACE (Major Adverse Cardiac Events) | - Compare the differences between the rate of MACE (all-cause death, any myocardial infarction and any revascularization) of Angiolite and Xience during follow-up | 1 year |
| León |
| León |
| 24001 |
| Spain |
| Hospital Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Infanta Cristina | Badajoz | 06006 | Spain |
| Hospital Valle de Hebrón | Barcelona | 08035 | Spain |
| Hospital Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Juan Ramón Jiménez | Huelva | 21005 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Marqués de Valdecilla | Santander | 39008 | Spain |
| Hospital Virgen de la Salud | Toledo | 45005 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47003 | Spain |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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