Robotic-Assisted Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
Percutaneous coronary intervention is a safe procedure. However, its execution is manual, fully operator-dependent. The procedure is also associated with radiation exposure to patients and physicians. This study will evaluate the robotic assisted percutaneous coronary intervention as an alternative to manual operation.

Official Title
-----------------
Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Robotic Assisted Percutaneous Coronary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> = 18 years; Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions; Elective for percutaneous procedure (i.e. performed in a non-urgent context) The target lesion (s) must be obstructive, with stenosis diameter > 50% (visual analysis); The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator; Acceptable candidate for myocardial revascularization surgery. Exclusion Criteria: ST-segment elevation myocardial infarction in the last 48 hours before the index procedure; Ejection fraction <30%; Impaired renal function (creatinine> 2.0 mg / dL) or calculated creatinine clearance <30 ml / min; Platelet count <100,000 cells / mm 3 or> 700,000 cells / mm 3; Total Leucocytes count <3,000 cells / mm 3; Suspected or documented active liver disease (including laboratory evidence of hepatitis); Heart transplant recipient; Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel; Patient with a life expectancy of less than 1 month; Any significant medical condition that in the opinion of the investigator may interfere with the patient's ideal participation in this study; Participation in other research in the last 12 months, unless there may be direct benefit to the research subject; Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure. Angiographic exclusion criteria Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month; Target lesion not accessible by robotic treatment, according to the judgment of the operator; Unprotected coronary artery trunk lesion (stenosis> 50%); Angiographic thrombus; Target lesion in surgical graft; Total occlusion (TIMI 0 or 1 anterograde flow)

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Assisted Percutaneous Coronary Intervention<br> | Procedure: Robotic Assisted Percutaneous Coronary Intervention<br>* Robotic Assisted Percutaneous Coronary Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Complications | Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment). | 1 day | 
| Procedure Success | Robotic Assisted Procedure Success | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of Major Events | Death, stent thrombosis, Myocardial Infarction, Stroke | 1 month |