Robotic-Assisted Percutaneous Coronary Intervention

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Robotic Assisted Percutaneous Coronary Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 83
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro Lemos, PhD; Phone Number: +55 (11) 2151-4306; Email: pedro.lemos@einstein.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Assisted Percutaneous Coronary Intervention	Procedure: Robotic Assisted Percutaneous Coronary Intervention; Robotic Assisted Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of Major Events	Death, stent thrombosis, Myocardial Infarction, Stroke	1 month

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Anticipated): June 10, 2019
• Primary Completion (Anticipated): February 10, 2020
• Study Completion (Anticipated): March 10, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (Actual): April 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Robotic First

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No