Coronary Artery DiseaseNCT03927560
Robotic-Assisted Percutaneous Coronary Intervention
A study testing Robotic Assisted Percutaneous Coronary Intervention in people with Coronary Artery Disease, run by Hospital Israelita Albert Einstein.
Trial summary
Percutaneous coronary intervention is a safe procedure. However, its execution is manual, fully operator-dependent. The procedure is also associated with radiation exposure to patients and physicians. This study will evaluate the robotic assisted percutaneous coronary intervention as an alternative to manual operation. 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?
- Robotic Assisted Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2019to 10 Mar 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;
- Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions;
- Elective for percutaneous procedure (i.e. performed in a non-urgent context)
- The target lesion (s) must be obstructive, with stenosis diameter > 50% (visual analysis);
- The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator;
- Acceptable candidate for myocardial revascularization surgery.
Who cannot join
- ST-segment elevation myocardial infarction in the last 48 hours before the index procedure;
- Ejection fraction <30%;
- Impaired renal function (creatinine> 2.0 mg / dL) or calculated creatinine clearance <30 ml / min;
- Platelet count <100,000 cells / mm 3 or> 700,000 cells / mm 3;
- Total Leucocytes count <3,000 cells / mm 3;
- Suspected or documented active liver disease (including laboratory evidence of hepatitis);
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- 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 opinion of the investigator may interfere with the patient's ideal participation in this study;
- Participation in other research in the last 12 months, unless there may be direct benefit to the research subject;
- Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure.
- Angiographic exclusion criteria
- Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month;
- Target lesion not accessible by robotic treatment, according to the judgment of the operator;
- Unprotected coronary artery trunk lesion (stenosis> 50%);
- Angiographic thrombus;
- Target lesion in surgical graft;
- Total occlusion (TIMI 0 or 1 anterograde flow)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System
Percutaneous coronary intervention is a safe procedure. However, its execution is manual, fully operator-dependent. The procedure is also associated with radiation exposure to patients and physicians. This study will evaluate the robotic assisted percutaneous coronary intervention as an alternative to manual operation.
- Conditions
- Coronary Artery Disease
- Being tested
- Robotic Assisted Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Assisted Percutaneous Coronary InterventionProcedure or surgery
Robotic Assisted Percutaneous Coronary Intervention
| Study group | Role | What they receive |
|---|---|---|
| Robotic Assisted Percutaneous Coronary Intervention | Experimental | Not described Receives: Procedure: Robotic Assisted Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Complications
Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).
Measured: 1 day
Procedure Success
Robotic Assisted Procedure Success
Measured: 1 day
Secondary outcomes (1)
Occurence of Major Events
Death, stent thrombosis, Myocardial Infarction, Stroke
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start10 Jun 2019 (estimated)
- Primary completion10 Feb 2020 (estimated)
- Study completion10 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927560
- Sponsor's protocol ID
- Robotic First
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System
- ClinicalTrials.gov ID
- NCT03927560
- Acronym / sponsor ID
- Robotic First
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 10 Jun 2019 (estimated)
- Primary completion
- 10 Feb 2020 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 25 Apr 2019 (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 coronary intervention is a safe procedure. However, its execution is manual, fully operator-dependent. The procedure is also associated with radiation exposure to patients and physicians. This study will evaluate the robotic assisted percutaneous coronary intervention as an alternative to manual operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic Assisted Percutaneous Coronary Intervention | Experimental | Procedure: Robotic Assisted Percutaneous Coronary Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age> = 18 years;
- Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions;
- Elective for percutaneous procedure (i.e. performed in a non-urgent context)
- The target lesion (s) must be obstructive, with stenosis diameter > 50% (visual analysis);
- The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator;
Key exclusion criteria (19 listed)
- ST-segment elevation myocardial infarction in the last 48 hours before the index procedure;
- Ejection fraction <30%;
- Impaired renal function (creatinine> 2.0 mg / dL) or calculated creatinine clearance <30 ml / min;
- Platelet count <100,000 cells / mm 3 or> 700,000 cells / mm 3;
- Total Leucocytes count <3,000 cells / mm 3;
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 |
|---|---|---|
| Robotic Assisted Percutaneous Coronary InterventionRobotic Assisted Percutaneous Coronary Intervention | Procedure or surgery | Robotic Assisted Percutaneous Coronary Intervention |
Primary outcome
Procedure Complications
Time frame: 1 day
Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).
Procedure Success
Time frame: 1 day
Robotic Assisted Procedure Success
1 secondary outcome
Occurence of Major Events
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Assisted Percutaneous Coronary Intervention in people with Coronary Artery Disease, run by Hospital Israelita Albert Einstein.
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 6 inclusion and 19 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 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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, PhD (+55 (11) 2151-4306, pedro.lemos@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Complications (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2019.