6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Three New Generation Drug Eluting Stent

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to compare at 6 months follow-up, endothelization and malapposition, evaluated by means of optical coherence tomography, in terms of number of struts not endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience.

Detailed Description
-----------------
This is a randomized study aimed at evaluating in 60 patients with either acute coronary syndromes or stable coronary artery disease submitted with PCI and stenting, endothelization and malapposition at 6 months follow-up (primary endpoint), evaluated by means of optical coherence tomography in terms of number of struts not re-endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience. Further clinical follow-up will be performed to evaluate MACE at 12 months follow-up.

Official Title
-----------------
6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Endothelization and Malapposition of Three New Generation Drug Eluting Stent: CRE8, Biomatrix and Xience

Conditions
-----------------
Recurrent Angina After Coronary Stent Placement

Intervention / Treatment
-----------------
* Device: optical coherence tomography at 6 months


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with stable angina or acute coronary syndromes submitted to coronary angioplasty on a coronary with a vessel diameter > 2,5 mm Exclusion Criteria: Known allergy to antithrombotic drugs or to other components of the stent studied Planned surgery 6 months within angioplasty

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CRE8 stent<br>Treatment with CRE8 stent implantation and evaluated with optical coherence tomography at 6 months | Device: optical coherence tomography at 6 months<br>* 6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography<br>|
| Active Comparator: Biomatrix stent<br>Treatment with Biomatrix stent implantation and evaluated with optical coherence tomography at 6 months | Device: optical coherence tomography at 6 months<br>* 6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography<br>|
| Active Comparator: patients treated with Xience stent<br>Treatment with Xience stent implantation and evaluated with optical coherence tomography at 6 months | Device: optical coherence tomography at 6 months<br>* 6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent struts coverage assessed by means of intracoronary optical coherence tomography |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization) |  | 12 months | 
| inducible ischemia at myocardial scintigraphy |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
optical coherence tomography, malapposition, endothelization