Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses

May 7, 2020 updated by: Hospital Israelita Albert Einstein

Percutaneous cardiovascular intervention procedures (e.g. coronary angioplasty, peripheral artery angioplasty) must be performed in person, requiring the physical presence of one or more medical, nursing and technical professionals. The control of catheters and interventional materials is performed manually, with the operator positioned next to the patient. This context results in potential for reciprocal exposure to exhaled air, both for the professionals involved and for the patient, with an inherent risk of aerial contamination. It is important to note that interventional procedures are often performed on an urgent or emergency basis (e.g. myocardial infarction), without the possibility of postponement or postponement.

The recent robot-assisted cardiovascular intervention makes it possible to modify this scenario by allowing the procedure to be performed effectively and safely in a position far from the patient. In an environment with high potential for contamination, mainly related to the current pandemic caused by the COVID-19 virus, may prove to be a tactic to expand hospital security.

It is in this sense that the present pilot proposal is inserted, which, ultimately, aims to evaluate the potential of robotic intervention as a strategy to reduce exposure to exhaled air of patients and professionals during the intervention procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Percutaneous cardiovascular intervention procedures (e.g. coronary angioplasty, peripheral artery angioplasty) must be performed in person, requiring the physical presence of one or more medical, nursing and technical professionals. The control of catheters and interventional materials is performed manually, with the operator positioned next to the patient. This context results in potential for reciprocal exposure to exhaled air, both for the professionals involved and for the patient, with an inherent risk of aerial contamination. It is important to note that interventional procedures are often performed on an urgent or emergency basis (e.g. myocardial infarction), without the possibility of postponement or postponement.

The recent robot-assisted cardiovascular intervention makes it possible to modify this scenario by allowing the procedure to be performed effectively and safely in a position far from the patient. In an environment with high potential for contamination, mainly related to the current pandemic caused by the COVID-19 virus, may prove to be a tactic to expand hospital security.

It is in this sense that the present pilot proposal is inserted, which, ultimately, aims to evaluate the potential of robotic intervention as a strategy to reduce exposure to exhaled air of patients and professionals during the intervention procedure.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05652- 900
        • Recruiting
        • Hospital Israelita Albert Einstein
        • Contact:
        • Sub-Investigator:
          • Marcelo Franken, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age> = 18 years;
  • Cardiovascular disease characterized by:
  • Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions OR
  • Symptomatic peripheral arterial disease and / or with objective evidence of the need for percutaneous intervention of one or more target lesions;
  • The target lesion (s) must be obstructive and / or aneurysmatic (visual analysis);
  • Interventionist planning for all target lesions should include robotic manipulation in at least one treatment period, according to the operator's judgment;
  • The patient will be informed about the nature of the study, agree with its rules and will provide written informed consent, approved by the local Ethics Committee.

Exclusion Criteria:

  • Platelet count <50,000 cells / mm3 or> 700,000 cells / mm3;
  • Total leukometry <3,000 cells / mm3;
  • Suspected or documented active liver disease, with blood dyscrasia with INR <1.5;
  • 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 investigator's opinion may interfere with the patient's ideal participation in this study;
  • Participation in another research in the last 12 months, unless there can be direct benefit to the research subject;
  • Any invasive cardiac or non-cardiac treatment scheduled in the first month after the index procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot Assisted Percutaneous Cardiovascular Intervention
Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Procedure: Robot Assisted Percutaneous Cardiovascular Intervention
Robot Assisted Percutaneous Cardiovascular Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful cardiovascular intervention
Time Frame: Until the end of the procedure
(arterial dilation with residual lesion <50% at angiography and normal anterograde flow)
Until the end of the procedure
Performed with the professional team positioned at> 2 meters from the patient for at least 50% of the duration of the intervention
Time Frame: Until the end of the procedure
Until the end of the procedure
absence of fatal complications caused by the procedure or acute non-fatal vessel occlusion during index admission
Time Frame: Until the end of the procedure
Until the end of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Pedro Lemos, MD, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 27, 2020

Primary Completion (Anticipated)

April 27, 2020

Study Completion (Anticipated)

April 27, 2020

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

May 6, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4094-20

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

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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