Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Robot Assisted Percutaneous Cardiovascular Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Robot Assisted Percutaneous Cardiovascular Intervention, COVID-19
Eligibility 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.
Sites / Locations
- Hospital Israelita Albert EinsteinRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robot Assisted Percutaneous Cardiovascular Intervention
Arm Description
Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Outcomes
Primary Outcome Measures
Successful cardiovascular intervention
(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
absence of fatal complications caused by the procedure or acute non-fatal vessel occlusion during index admission
Secondary Outcome Measures
Full Information
NCT ID
NCT04379453
First Posted
April 27, 2020
Last Updated
May 7, 2020
Sponsor
Hospital Israelita Albert Einstein
1. Study Identification
Unique Protocol Identification Number
NCT04379453
Brief Title
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
Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2020 (Anticipated)
Primary Completion Date
April 27, 2020 (Anticipated)
Study Completion Date
April 27, 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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Robot Assisted Percutaneous Cardiovascular Intervention, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot Assisted Percutaneous Cardiovascular Intervention
Arm Type
Experimental
Arm Description
Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Intervention Type
Procedure
Intervention Name(s)
Robot Assisted Percutaneous Cardiovascular Intervention
Intervention Description
Robot Assisted Percutaneous Cardiovascular Intervention
Primary Outcome Measure Information:
Title
Successful cardiovascular intervention
Description
(arterial dilation with residual lesion <50% at angiography and normal anterograde flow)
Time Frame
Until the end of the procedure
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Lemos, MD
Phone
+55 (11)98317-5000
Email
pedro.lemos@einstein.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Lemos, MD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05652- 900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro A Lemos, MD
Phone
+55 (11) 2151-0449
Email
pedro.lemos@einstein.br
First Name & Middle Initial & Last Name & Degree
Marcelo Franken, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33834847
Citation
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 Aug;17(5):865-873. doi: 10.2217/fca-2021-0024. Epub 2021 Apr 9.
Results Reference
derived
Learn more about this trial
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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