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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
220
Percutaneous coronary intervention
Percutaneous coronary intervention
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital de León
León, León, Spain
Hospital Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Infanta Cristina
Badajoz, Spain
Hospital Valle de Hebrón
Barcelona, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital Juan Ramón Jiménez
Huelva, Spain
Hospital La Paz
Madrid, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Virgen de la Salud
Toledo, Spain
...and 1 more locations
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)
Time frame: 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
Time frame: 1 year
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
Time frame: 1 year
Thrombosis rate
Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience
Time frame: 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
Time frame: 1 year
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