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Robotic-Assisted Percutaneous Coronary Intervention

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Robotic Assisted Percutaneous Coronary Intervention

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age> = 18 years;
Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions;
Elective for percutaneous procedure (i.e. performed in a non-urgent context)
The target lesion (s) must be obstructive, with stenosis diameter > 50% (visual analysis);
The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator;
Acceptable candidate for myocardial revascularization surgery.

Exclusion Criteria:

ST-segment elevation myocardial infarction in the last 48 hours before the index procedure;
Ejection fraction <30%;
Impaired renal function (creatinine> 2.0 mg / dL) or calculated creatinine clearance <30 ml / min;
Platelet count <100,000 cells / mm 3 or> 700,000 cells / mm 3;
Total Leucocytes count <3,000 cells / mm 3;
Suspected or documented active liver disease (including laboratory evidence of hepatitis);
Heart transplant recipient;
Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel;
Patient with a life expectancy of less than 1 month;
Any significant medical condition that in the opinion of the investigator may interfere with the patient's ideal participation in this study;
Participation in other research in the last 12 months, unless there may be direct benefit to the research subject;
Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure.

Angiographic exclusion criteria

Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month;
Target lesion not accessible by robotic treatment, according to the judgment of the operator;
Unprotected coronary artery trunk lesion (stenosis> 50%);
Angiographic thrombus;
Target lesion in surgical graft;
Total occlusion (TIMI 0 or 1 anterograde flow)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robotic Assisted Percutaneous Coronary Intervention

Arm Description

Outcomes

Primary Outcome Measures

Procedure Complications

Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).

Procedure Success

Robotic Assisted Procedure Success

Secondary Outcome Measures

Occurence of Major Events

Death, stent thrombosis, Myocardial Infarction, Stroke

Full Information

NCT ID

NCT03927560

First Posted

April 22, 2019

Last Updated

April 29, 2019

Sponsor

Hospital Israelita Albert Einstein

1. Study Identification

Unique Protocol Identification Number

NCT03927560

Brief Title

Robotic-Assisted Percutaneous Coronary Intervention

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 10, 2019 (Anticipated)

Primary Completion Date

February 10, 2020 (Anticipated)

Study Completion Date

March 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

83 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Robotic Assisted Percutaneous Coronary Intervention

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Robotic Assisted Percutaneous Coronary Intervention

Intervention Description

Robotic Assisted Percutaneous Coronary Intervention

Primary Outcome Measure Information:

Title

Procedure Complications

Description

Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).

Time Frame

1 day

Title

Procedure Success

Description

Robotic Assisted Procedure Success

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Occurence of Major Events

Description

Death, stent thrombosis, Myocardial Infarction, Stroke

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age> = 18 years; Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions; Elective for percutaneous procedure (i.e. performed in a non-urgent context) The target lesion (s) must be obstructive, with stenosis diameter > 50% (visual analysis); The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator; Acceptable candidate for myocardial revascularization surgery. Exclusion Criteria: ST-segment elevation myocardial infarction in the last 48 hours before the index procedure; Ejection fraction <30%; Impaired renal function (creatinine> 2.0 mg / dL) or calculated creatinine clearance <30 ml / min; Platelet count <100,000 cells / mm 3 or> 700,000 cells / mm 3; Total Leucocytes count <3,000 cells / mm 3; Suspected or documented active liver disease (including laboratory evidence of hepatitis); Heart transplant recipient; Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel; Patient with a life expectancy of less than 1 month; Any significant medical condition that in the opinion of the investigator may interfere with the patient's ideal participation in this study; Participation in other research in the last 12 months, unless there may be direct benefit to the research subject; Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure. Angiographic exclusion criteria Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month; Target lesion not accessible by robotic treatment, according to the judgment of the operator; Unprotected coronary artery trunk lesion (stenosis> 50%); Angiographic thrombus; Target lesion in surgical graft; Total occlusion (TIMI 0 or 1 anterograde flow)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pedro Lemos, PhD

Phone

+55 (11) 2151-4306

pedro.lemos@einstein.br

12. IPD Sharing Statement

Plan to Share IPD

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Robotic-Assisted Percutaneous Coronary Intervention

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