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Robotic-Assisted Percutaneous Coronary Intervention

  • identifier


  • Recruitment Status

    Not yet recruiting

  • First Posted

    April 25, 2019

  • Last update posted

    May 1, 2019

Study Description

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:Coronary Artery Disease
  • Intervention/Treatment: Procedure: Robotic Assisted Percutaneous Coronary Intervention
  • Phase: N/A

Detailed Description


Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 83 participants
  • 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 2019
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: March 2020

Arms and interventions

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

Outcome Measures

  • 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

Eligibility Criteria

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


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

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

2. Ejection fraction 2.0 mg / dL) or calculated creatinine clearance
<30 ml / min; 4. Platelet count 700,000 cells / mm 3;

5. Total Leucocytes count 50%);

4. Angiographic thrombus;

5. Target lesion in surgical graft;

6. Total occlusion (TIMI 0 or 1 anterograde flow)

Contacts and Locations


Contact: Pedro Lemos, PhD +55 (11) 2151-4306


Sponsors and Collaborators

Hospital Israelita Albert Einstein

More Information

  • Responsible Party: Hospital Israelita Albert Einstein
  • Identifier: NCT03927560 History of Changes
  • 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

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Coronary Artery Disease