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Robotic-Assisted Percutaneous Coronary Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927560
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Robotic Assisted Percutaneous Coronary Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System
Estimated Study Start Date : June 10, 2019
Estimated Primary Completion Date : February 10, 2020
Estimated Study Completion Date : March 10, 2020

Arm Intervention/treatment
Experimental: Robotic Assisted Percutaneous Coronary Intervention Procedure: Robotic Assisted Percutaneous Coronary Intervention
Robotic Assisted Percutaneous Coronary Intervention




Primary Outcome Measures :
  1. 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).

  2. Procedure Success [ Time Frame: 1 day ]
    Robotic Assisted Procedure Success


Secondary Outcome Measures :
  1. Occurence of Major Events [ Time Frame: 1 month ]
    Death, stent thrombosis, Myocardial Infarction, Stroke



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age> = 18 years;
  2. Symptomatic ischemic heart disease and / or objective evidence of myocardial ischemia with one or more target lesions;
  3. Elective for percutaneous procedure (i.e. performed in a non-urgent context)
  4. The target lesion (s) must be obstructive, with stenosis diameter > 50% (visual analysis);
  5. The interventional planning of all target lesions should include robotic manipulation in at least one treatment, as judged by the operator;
  6. Acceptable candidate for myocardial revascularization surgery.

Exclusion Criteria:

  1. ST-segment elevation myocardial infarction in the last 48 hours before the index procedure;
  2. Ejection fraction <30%;
  3. Impaired renal function (creatinine> 2.0 mg / dL) or calculated creatinine clearance <30 ml / min;
  4. Platelet count <100,000 cells / mm 3 or> 700,000 cells / mm 3;
  5. Total Leucocytes count <3,000 cells / mm 3;
  6. Suspected or documented active liver disease (including laboratory evidence of hepatitis);
  7. Heart transplant recipient;
  8. Allergies known to aspirin, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin, antiproliferative agents of the limus family, or stainless steel;
  9. Patient with a life expectancy of less than 1 month;
  10. Any significant medical condition that in the opinion of the investigator may interfere with the patient's ideal participation in this study;
  11. Participation in other research in the last 12 months, unless there may be direct benefit to the research subject;
  12. Any invasive cardiac or non-cardiac treatment scheduled within the first month after the index procedure.

Angiographic exclusion criteria

  1. Need for non-robotic (i.e. manual) treatment of another injury in the index procedure or in the first month;
  2. Target lesion not accessible by robotic treatment, according to the judgment of the operator;
  3. Unprotected coronary artery trunk lesion (stenosis> 50%);
  4. Angiographic thrombus;
  5. Target lesion in surgical graft;
  6. Total occlusion (TIMI 0 or 1 anterograde flow)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927560


Contacts
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Contact: Pedro Lemos, PhD +55 (11) 2151-4306 pedro.lemos@einstein.br

Sponsors and Collaborators
Hospital Israelita Albert Einstein
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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03927560    
Other Study ID Numbers: Robotic First
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases