Robotic-Assisted Percutaneous Coronary Intervention

Coronary Artery Disease Clinical Trial

Official title:

Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03927560
• Other study ID #: Robotic First
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: April 2019
• Source: Hospital Israelita Albert Einstein
• Contact: Pedro Lemos, PhD
• Phone: +55 (11) 2151-4306
• Email: pedro.lemos[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 83
• Est. completion date: March 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Robotic Assisted Percutaneous Coronary Intervention
Robotic Assisted Percutaneous Coronary Intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure Complications	Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).	1 day
Primary	Procedure Success	Robotic Assisted Procedure Success	1 day
Secondary	Occurence of Major Events	Death, stent thrombosis, Myocardial Infarction, Stroke	1 month