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出境医 / 临床实验 / Robotic-Assisted Percutaneous Coronary Intervention

Robotic-Assisted Percutaneous Coronary Intervention

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

Study Design
Layout table for study information
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
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
Layout table for eligibility information
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)
Contacts and Locations

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

Sponsors and Collaborators
Hospital Israelita Albert Einstein
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date May 1, 2019
Estimated Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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).
  • Procedure Success [ Time Frame: 1 day ]
    Robotic Assisted Procedure Success
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019) 		Occurence of Major Events [ Time Frame: 1 month ]
Death, stent thrombosis, Myocardial Infarction, Stroke
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019) 		Major Events [ Time Frame: 1 month ]
Death, stent thrombosis, Myocardial Infarction, Stroke
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robotic-Assisted Percutaneous Coronary Intervention
Official Title  ICMJE Robotic-Assisted Percutaneous Coronary Intervention - A Safety and Effectiveness Study Applied to the Brazilian Public Health System
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Procedure: Robotic Assisted Percutaneous Coronary Intervention
Robotic Assisted Percutaneous Coronary Intervention
Study Arms  ICMJE Experimental: Robotic Assisted Percutaneous Coronary Intervention
Intervention: Procedure: Robotic Assisted Percutaneous Coronary Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 24, 2019) 		83
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 10, 2020
Estimated Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927560
Other Study ID Numbers  ICMJE Robotic First
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Hospital Israelita Albert Einstein
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Israelita Albert Einstein
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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