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Clinical Trials/NCT03927560
NCT03927560UnknownNot Applicable

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

Hospital Israelita Albert Einstein0 sites83 target enrollmentStarted: June 10, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
83
Primary Endpoint
Procedure Success
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Robotic Assisted Percutaneous Coronary Intervention

Experimental

Intervention: Robotic Assisted Percutaneous Coronary Intervention (Procedure)

Outcomes

Primary Outcomes

Procedure Success

Time Frame: 1 day

Robotic Assisted Procedure Success

Procedure Complications

Time Frame: 1 day

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

Secondary Outcomes

  • Occurence of Major Events(1 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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