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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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Robotic-Assisted Percutaneous Coronary Intervention

  • Clinicaltrials.gov identifier

    NCT03927560

  • 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

N/A

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

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 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

Contacts

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

Locations

Sponsors and Collaborators

Hospital Israelita Albert Einstein

More Information

  • Responsible Party: Hospital Israelita Albert Einstein
  • ClinicalTrials.gov 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
    Statement:

  • 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