Coronary Artery Disease
Conditions
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.
Interventions
PROCEDURERobotic Assisted Percutaneous Coronary Intervention
Robotic Assisted Percutaneous Coronary Intervention
Sponsors
Hospital Israelita Albert Einstein
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age\> = 18 years; 2. Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions; 3. Elective for percutaneous procedure (i.e. performed in a non-urgent context) 4. The target lesion (s) must be obstructive, with stenosis diameter \> 50% (visual analysis); 5. The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator; 6. Acceptable candidate for myocardial revascularization surgery.
Exclusion criteria
1. ST-segment elevation myocardial infarction in the last 48 hours before the index procedure; 2. Ejection fraction \<30%; 3. Impaired renal function (creatinine\> 2.0 mg / dL) or calculated creatinine clearance \<30 ml / min; 4. Platelet count \<100,000 cells / mm 3 or\> 700,000 cells / mm 3; 5. Total Leucocytes count \<3,000 cells / mm 3; 6. Suspected or documented active liver disease (including laboratory evidence of hepatitis); 7. Heart transplant recipient; 8. Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel; 9. Patient with a life expectancy of less than 1 month; 10. Any significant medical condition that in the opinion of the investigator may interfere with the patient's ideal participation in this study; 11. Participation in other research in the last 12 months, unless there may be direct benefit to the research subject; 12. Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Complications | 1 day | Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment). |
| Procedure Success | 1 day | Robotic Assisted Procedure Success |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of Major Events | 1 month | Death, stent thrombosis, Myocardial Infarction, Stroke |
Contacts
Primary ContactPedro Lemos, PhD
Outcome results
None listed