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

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ClinicalTrials.gov Identifier: NCT04379453
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

Tracking Information
First Submitted Date  ICMJE April 27, 2020
First Posted Date  ICMJE May 7, 2020
Last Update Posted Date May 8, 2020
Estimated Study Start Date  ICMJE April 27, 2020
Estimated Primary Completion Date April 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • Successful cardiovascular intervention [ Time Frame: Until the end of the procedure ]
    (arterial dilation with residual lesion <50% at angiography and normal anterograde flow)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Official Title  ICMJE Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Procedure: Robot Assisted Percutaneous Cardiovascular Intervention
Robot Assisted Percutaneous Cardiovascular Intervention
Study Arms  ICMJE 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
Intervention: Procedure: Robot Assisted Percutaneous Cardiovascular Intervention
Publications * Lemos PA, Franken M, Mariani J Jr, Pitta FG, Oliveira FA, Cunha-Lima G, Caixeta AM, Almeida BO, Garcia RG. Use of robotic assistance to reduce proximity and air-sharing during percutaneous cardiovascular intervention. Future Cardiol. 2021 Apr 9. doi: 10.2217/fca-2021-0024. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 27, 2020
Estimated Primary Completion Date April 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pedro Lemos, MD +55 (11)98317-5000 pedro.lemos@einstein.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04379453
Other Study ID Numbers  ICMJE 4094-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Hospital Israelita Albert Einstein
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pedro Lemos, MD Hospital Israelita Albert Einstein
PRS Account Hospital Israelita Albert Einstein
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP