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PRECISION GRX Registry

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ClinicalTrials.gov Identifier: NCT03278301
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.

Brief Summary:
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Robotic-assisted PCI

Detailed Description:
This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
Actual Study Start Date : August 27, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Intervention Details:
  • Device: Robotic-assisted PCI
    The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.


Primary Outcome Measures :
  1. Clinical Success [ Time Frame: Discharge or 72 hours post intervention, whichever comes first. ]
    Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse coronary events (MACE).

  2. Technical Success [ Time Frame: Procedure ]
    Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.


Secondary Outcome Measures :
  1. Overall Procedure Time [ Time Frame: Procedure ]
    Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

  2. PCI Procedure Time [ Time Frame: Procedure ]
    Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

  3. Fluoroscopy Time [ Time Frame: Procedure ]
    Total Fluoroscopy Time during procedure will be captured.

  4. Patient Radiation Exposure [ Time Frame: Procedure ]
    DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with coronary artery disease and with a clinical indication for PCI.
Criteria

Inclusion Criteria:

Candidates will be included in the study only if all of the following conditions are met:

  1. Age ≥18 years;
  2. Patients with coronary artery disease with clinical indication for PCI;
  3. Patient deemed appropriate for robotic-assisted PCI; and
  4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  • Candidates will be excluded from the study if any of the following conditions are present:

    1. Failure/inability/unwillingness to provide informed consent; or
    2. The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

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): NCT03278301


Contacts
Contact: Tina Ridgeway, BS, RN 508-653-3335 ext 202 tina.ridgeway@corindus.com

Locations
United States, California
UC San Diego Health Sulpizio Cardiovascular Center Recruiting
San Diego, California, United States, 92037
Contact: Bahman Ghannadian, MD       bghannadian@mail.ucsd.edu   
Principal Investigator: Ehtisham Mahmud, MD         
United States, Michigan
Spectrum Health Hospitals Fred and Lena Meijer Heart Center Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Stacie Vanoosterhout, MS       stacie.vanoosterhout@spectrumhealth.org   
Principal Investigator: Ryan Madder, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Ervin Mazniku       emazniku@montefiore.org   
Principal Investigator: Giora Weisz, MD         
New York-Presbyterian Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Andy Morales       am2513@columbia.edu   
Principal Investigator: Manish Parikh, MD         
United States, North Carolina
WakeMed Raleigh Campus Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Annsley Winders       awinders@wakemed.org   
Principal Investigator: Frances Wood, MD         
United States, Pennsylvania
Wellspan York Hospital Recruiting
York, Pennsylvania, United States, 17405
Contact: Elayne Grim       egrim@wellspan.org   
Principal Investigator: William J Nicholson, MD         
United States, Tennessee
Jackson-Madison County General Hospital Recruiting
Jackson, Tennessee, United States, 38301
Contact: Mary Harris, MSN, RN       Mary.Harris@WTH.org   
Principal Investigator: John Baker, MD         
United States, Texas
Baylor Jack and Jane Hamilton Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75226
Contact: Janet Dunkerley, RN       Janet.Dunkerley@BSWHealth.org   
Sub-Investigator: Jeffery Schussler, MD         
Baylor Scott and White All Saints Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Contact: Theresa Cheney, RN       Theresa.Cheyne@BSWHealth.org   
Sub-Investigator: Farhan Ali, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Wesley Oglesby, BSN       woglesby@houstonmethodist.org   
Principal Investigator: Alpesh Shah, MD         
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Kathryn Shinn       KATHRYN.SHINN@BSWHEALTH.ORG   
Principal Investigator: Srinivasa Potluri, MD         
United States, Virginia
University of Virginia Health System University Hospital Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Linda Bailes, RN       lgs2m@hscmail.mcc.virginia.edu   
Principal Investigator: Michael Ragosta, MD         
Sponsors and Collaborators
Corindus Inc.
Investigators
Principal Investigator: Ehtisham Mahmud, MD University of California, San Diego

Responsible Party: Corindus Inc.
ClinicalTrials.gov Identifier: NCT03278301     History of Changes
Other Study ID Numbers: 2017-001
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases