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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04379453
• Other study ID #: 4094-20
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2020
• Est. completion date: April 27, 2020

Study information

• Verified date: April 2020
• Source: Hospital Israelita Albert Einstein
• Contact: Pedro Lemos, MD
• Phone: +55 (11)98317-5000
• Email: pedro.lemos[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Robot Assisted Percutaneous Cardiovascular Intervention
Robot Assisted Percutaneous Cardiovascular Intervention

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

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