Robotic-Assisted Percutaneous Coronary Intervention

NCT03927560 | Unknown

• 1 other identifier: Robotic First
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Procedure Complications

  Death or non-fatal major acute complications on the target vessel (thrombosis, myocardial infarction, perforation or non-planned invasive treatment).

  1 day

• Procedure Success

  Robotic Assisted Procedure Success

  1 day

Secondary Outcomes (1)

• Occurence of Major Events

  1 month

Study Arms (1)

Robotic Assisted Percutaneous Coronary Intervention

EXPERIMENTAL

Procedure: Robotic Assisted Percutaneous Coronary Intervention

Interventions

Robotic Assisted Percutaneous Coronary Intervention PROCEDURE

Robotic Assisted Percutaneous Coronary Intervention

Robotic Assisted Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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.
• 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%);

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Pedro Lemos, PhD

CONTACT

+55 (11) 2151-4306; pedro.lemos@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 25, 2019
• Study Start: June 10, 2019
• Primary Completion: February 10, 2020
• Study Completion: March 10, 2020
• Last Updated: May 1, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share