Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03927560
Eligibility Criteria:
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 exclusion criteria
1. Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month;
2. Target lesion not accessible by robotic treatment, according to the judgment of the operator;
3. Unprotected coronary artery trunk lesion (stenosis\> 50%);
4. Angiographic thrombus;
5. Target lesion in surgical graft;
6. Total occlusion (TIMI 0 or 1 anterograde flow)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03927560
Study Brief:
Protocol Section:
NCT03927560