Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 83
- Primary Endpoint
- Procedure Success
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Robotic Assisted Percutaneous Coronary Intervention
Intervention: Robotic Assisted Percutaneous Coronary Intervention (Procedure)
Outcomes
Primary Outcomes
Procedure Success
Time Frame: 1 day
Robotic Assisted Procedure Success
Procedure Complications
Time Frame: 1 day
Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).
Secondary Outcomes
- Occurence of Major Events(1 month)
