Coronary Artery Disease, Drug-eluting Stent
Conditions
Brief summary
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)
Interventions
Sponsors
Cardiva2 S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with clinical or subclinical ischemic heart disease with indication of percutaneous revascularization. * De Novo lesions ≥ 70% * Reference diameters ≥ 2 mm and ≤ 4 mm Accepted participation in the registration with the signing of informed consent
Exclusion criteria
* Cardiogenic shock * Pregnancy * Intolerance or allergy to anti platelet or anticoagulant therapy * Elective surgical procedure scheduled within 6 months after inclusion in the study * Expectancy of life of less than 1 year. * Impossibility of doing 1 year clinical follow-up. * Primary angioplasty in patients with killip class III-IV or mechanical complications. * Patient with pre-procedure restenosis. * Patients who will not be treated all lesions with the Angiolite stent. * Total occlusions * Truncus disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 months | 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) |
| Safety:Compare TLF rate (cardiovascular death, target vessel-related myocardial infarction (MI) with definite thrombosis or ischemia-driven Target Lesion Revascularization (TLR)) | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow up | 1 year | 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 |
| Thrombosis rate | 1 year | Discard differences in definite and probable thrombosis rate (according to Academic Research Consortium criteria) between both stents Angiolite and Xience |
| MACE (Major Adverse Cardiac Events) | 1 year | \- Compare the differences between the rate of MACE (all-cause death, any myocardial infarction and any revascularization) of Angiolite and Xience during follow-up |
Countries
Spain
Outcome results
None listed