Robotic-Assisted Percutaneous Coronary Intervention

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Robotic Assisted Percutaneous Coronary Intervention

• Registration Number: NCT03927560
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-25
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01
• Study Start: 2019-06-10
• Primary Completion: 2020-02-10
• Study Completion: 2020-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 83

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic Assisted Percutaneous Coronary Intervention	Robotic Assisted Percutaneous Coronary Intervention	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Occurence of Major Events	1 month	Death, stent thrombosis, Myocardial Infarction, Stroke