Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention

Study Overview
=================
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)

Official Title
-----------------
Randomized Clinical Trial to Compare the Efficacy of Angiolite Stent Versus a Second-generation Drug-eluting Stent Such as Xience in Patients With Indication of Percutaneous Coronary Intervention

Conditions
-----------------
Coronary Artery Disease, Drug-eluting Stent

Intervention / Treatment
-----------------
* Device: Angiolite
* Device: Xience


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ANGIOLITE<br>Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent. | Device: Angiolite<br>* Percutaneous coronary intervention<br>|
| Active Comparator: Xience<br>Compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent. | Device: Xience<br>* Percutaneous coronary intervention<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |