Coronary Artery DiseaseNCT04379453
Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
A study testing Robot Assisted Percutaneous Cardiovascular Intervention in people with Coronary Artery Disease, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Robot Assisted Percutaneous Cardiovascular Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Apr 2020to 27 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, 05652- 900
Pedro A Lemos, MD, +55 (11) 2151-0449, pedro.lemos@einstein.br
Marcelo Franken, MD
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Robot Assisted Percutaneous Cardiovascular Intervention
- Keywords
- Coronary Artery Disease, Robot Assisted Percutaneous Cardiovascular Intervention, COVID-19
- Medical subject headings
- Coronary Artery Disease, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Assisted Percutaneous Cardiovascular InterventionProcedure or surgery
Robot Assisted Percutaneous Cardiovascular Intervention
| Study group | Role | What they receive |
|---|---|---|
| Robot Assisted Percutaneous Cardiovascular Intervention | Experimental | Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses Receives: Procedure: Robot Assisted Percutaneous Cardiovascular Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful cardiovascular intervention
(arterial dilation with residual lesion <50% at angiography and normal anterograde flow)
Measured: 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
Measured: Until the end of the procedure
absence of fatal complications caused by the procedure or acute non-fatal vessel occlusion during index admission
Measured: Until the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start27 Apr 2020 (estimated)
- Primary completion27 Apr 2020 (estimated)
- Study completion27 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro Lemos, MD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379453
- Sponsor's protocol ID
- 4094-20
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33834847
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04379453
- Acronym / sponsor ID
- 4094-20
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Robot Assisted Percutaneous Cardiovascular Intervention, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 27 Apr 2020 (estimated)
- Primary completion
- 27 Apr 2020 (estimated)
- Study completion
- 27 Apr 2020 (estimated)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Percutaneous Cardiovascular Intervention | Experimental | Procedure: Robot Assisted Percutaneous Cardiovascular InterventionRobot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot Assisted Percutaneous Cardiovascular InterventionRobot Assisted Percutaneous Cardiovascular Intervention | Procedure or surgery | Robot Assisted Percutaneous Cardiovascular Intervention |
Primary outcome
Successful cardiovascular intervention
Time frame: Until the end of the procedure
(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
Time frame: Until the end of the procedure
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 33834847Lemos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Lemos, MD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Assisted Percutaneous Cardiovascular Intervention in people with Coronary Artery Disease, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pedro Lemos, MD (+55 (11)98317-5000, pedro.lemos@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful cardiovascular intervention (time frame: Until the end of the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.