Robotic-Assisted Percutaneous Coronary Intervention

Hospital Israelita Albert Einstein

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Procedure: Robotic Assisted Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03927560

Robotic First

Details and patient eligibility

About

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.

Enrollment: 83 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

83 participants in 1 patient group

Robotic Assisted Percutaneous Coronary Intervention

Experimental group

Treatment:

Procedure: Robotic Assisted Percutaneous Coronary Intervention