Robotic-Assisted Percutaneous Coronary Intervention

NCT ID: NCT03927560

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2020-03-10

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic Assisted Percutaneous Coronary Intervention

Group Type: EXPERIMENTAL

Robotic Assisted Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Robotic Assisted Percutaneous Coronary Intervention

Interventions

Robotic Assisted Percutaneous Coronary Intervention

Robotic Assisted Percutaneous Coronary Intervention

Intervention Type: PROCEDURE

Eligibility 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.

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pedro Lemos, PhD

Role: CONTACT

pedro.lemos@einstein.br

+55 (11) 2151-4306

Other Identifiers

Robotic First

Identifier Type: -

Identifier Source: org_study_id