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CorPath GRX STEMI Study (TREAT) (TREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459299
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.

Brief Summary:
This study will evaluate the performance of the CorPath GRX System in Robotic Primary PCI (RPPCI) in the treatment of ST-elevated myocardial infarction (STEMI).

Condition or disease Intervention/treatment
STEMI - ST Elevation Myocardial Infarction CAD Procedure: Robotic-PCI (CorPath GRX System)

Detailed Description:
This is a prospective, post-market, single-arm, multi-center, observational study to evaluate the performance of the CorPath GRX System during robotic-PCI for acute ST elevation myocardial infarction (STEMI).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Performance of the CorPath® GRX System in Robotic-PCI During Acute STEMI
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
STEMI patients with clinical indication for primary PCI
Subjects with a clinical indication of STEMI.
Procedure: Robotic-PCI (CorPath GRX System)
Robotic-PCI for acute ST elevation myocardial infarction (STEMI).




Primary Outcome Measures :
  1. Time from Catheterization Lab Arrival to Device Activation (CLADA) by CorPath GRX System. [ Time Frame: Procedure ]
    Time measured from arrival to Cath Lab to device activation by CorPath GRX System.


Secondary Outcome Measures :
  1. Freedom from MACE events [ Time Frame: 72-hours ]
    Completion of the STEMI procedure without in-hospital major adverse cardiovascular event MACE). MACE is defined as cardiac death, clinically driven target vessel revascularization (TVR) by repeat PCI, surgical bypass for any segment of the target vessel or stent thrombosis.

  2. First Medical Contact (FMC) to device activation time [ Time Frame: Procedure ]
    Time at which first patient evaluation.

  3. Access to device activation [ Time Frame: Procedure ]
    Time measured from access sheath insertion to device activation by CorPath GRX System.

  4. Access to wire time [ Time Frame: Procedure ]
    Defined as time measured from sheath insertion to crossing the lesion with the coronary guidewire.

  5. Overall procedure time [ Time Frame: Procedure ]
    Defined as the time measured from sheath insertion to removal of the last device used to treat the culprit lesion.

  6. Fluoroscopy time [ Time Frame: Procedure ]
    Total fluoroscopy time (min.) utilized during the procedure as recorded by the Imaging System.

  7. Patient radiation exposure [ Time Frame: Procedure ]
    DAP (dose-area-product) and AK (air kerma) as recorded during the procedure.

  8. Contrast fluid volume [ Time Frame: Procedure ]
    Total contrast volume (mL/cc) used during the procedure.

  9. Conversion to manual (Binary) [ Time Frame: Procedure ]
    Conversion from robotic technique to manual technique due to inability to successfully wire lesion or deliver first device.

  10. Technical success [ Time Frame: Procedure ]
    Completion of the PCI procedure entirely robotically or with partial manual assistance.

  11. Serious adverse events [ Time Frame: 72-hours ]
    All Serious Adverse Events (SAEs) from the start of the CorPath GRX procedure until the end of the study will be summarized.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a clinical indication of STEMI.
Criteria

Inclusion Criteria:

  • Age ≥18 and ≤ 80 years
  • Patients with STEMI<12 h of symptom onset
  • Patient deemed appropriate for robotic-assisted PCI
  • The subject has been informed of the nature of the study, agrees to its provisions, and has provided written consent

Exclusion Criteria:

Cardiogenic shock

  • Cardiac arrest
  • Need for manual or mechanical thrombectomy
  • Failure/inability/unwillingness to provide informed consent
  • The Investigator determines that the subject or the coronary anatomy is not suitable for robotic-assisted primary PCI treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459299


Contacts
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Contact: Tina Ridgeway, BS, RN 757-810-5166 tina.ridgeway@corindus.com
Contact: John Van Vleet, MS 206-616-3541 john.vanvleet@corindus.com

Sponsors and Collaborators
Corindus Inc.
Investigators
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Study Chair: Salvatore F Mannino, DO, MA WellStar Health System
  Study Documents (Full-Text)

Documents provided by Corindus Inc.:
Study Protocol  [PDF] June 3, 2020

Publications:

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Responsible Party: Corindus Inc.
ClinicalTrials.gov Identifier: NCT04459299    
Other Study ID Numbers: 104-09062
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be available 12 months after study completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases