Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2020
CompletedStudy Start
First participant enrolled
April 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedMay 8, 2020
April 1, 2020
Same day
April 27, 2020
May 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Successful cardiovascular intervention
(arterial dilation with residual lesion \<50% at angiography and normal anterograde flow)
Until the end of the procedure
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
absence of fatal complications caused by the procedure or acute non-fatal vessel occlusion during index admission
Until the end of the procedure
Study Arms (1)
Robot Assisted Percutaneous Cardiovascular Intervention
EXPERIMENTALRobot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Interventions
Robot Assisted Percutaneous Cardiovascular Intervention
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Israelita Albert Einstein
São Paulo, 05652- 900, Brazil
Related Publications (1)
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.
PMID: 33834847DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pedro Lemos, MD
Hospital Israelita Albert Einstein
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2020
First Posted
May 7, 2020
Study Start
April 27, 2020
Primary Completion
April 27, 2020
Study Completion
April 27, 2020
Last Updated
May 8, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share