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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

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Robot Assisted Percutaneous Cardiovascular Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Estimated Study Start Date : April 27, 2020
Estimated Primary Completion Date : April 27, 2020
Estimated Study Completion Date : April 27, 2020

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




Primary Outcome Measures :
  1. Successful cardiovascular intervention [ Time Frame: Until the end of the procedure ]
    (arterial dilation with residual lesion <50% at angiography and normal anterograde flow)

  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379453


Contacts
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Contact: Pedro Lemos, MD +55 (11)98317-5000 pedro.lemos@einstein.br

Locations
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Brazil
Hospital Israelita Albert Einstein Recruiting
São Paulo, Brazil, 05652- 900
Contact: Pedro A Lemos, MD    +55 (11) 2151-0449    pedro.lemos@einstein.br   
Sub-Investigator: Marcelo Franken, MD         
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
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Principal Investigator: Pedro Lemos, MD Hospital Israelita Albert Einstein
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT04379453    
Other Study ID Numbers: 4094-20
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Hospital Israelita Albert Einstein:
Coronary Artery Disease
Robot Assisted Percutaneous Cardiovascular Intervention
COVID-19
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases