Clinical trial NCT04379453: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Robot Assisted Percutaneous Cardiovascular Intervention
COVID-19
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Successful cardiovascular intervention
timeFrame: Until the end of the procedure
measure: Performed with the professional team positioned at> 2 meters from the patient for at least 50% of the duration of the intervention
timeFrame: Until the end of the procedure
measure: absence of fatal complications caused by the procedure or acute non-fatal vessel occlusion during index admission
timeFrame: Until the end of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Pedro Lemos, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.