Status:
UNKNOWN
Robot Assisted Percutaneous Cardiovascular Intervention as a Strategy to Reduce or Risk of Intra-Procedure Contamination by COVID-19 and Other Respiratory Viruses
Lead Sponsor:
Hospital Israelita Albert Einstein
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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, nurs...
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, nurs...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 27 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04379453
Start Date
April 27 2020
End Date
April 27 2020
Last Update
May 8 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Israelita Albert Einstein
São Paulo, Brazil, 05652- 900