COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu


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. Read our disclaimer for details. Identifier: NCT03278301
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : February 10, 2020
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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 952 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
Actual Primary Completion Date : February 6, 2020
Actual Study Completion Date : February 6, 2020

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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
Sampling Method:   Non-Probability Sample
Study Population
Subjects with coronary artery disease and with a clinical indication for PCI.

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 identifier (NCT number): NCT03278301

Show Show 19 study locations
Sponsors and Collaborators
Corindus Inc.
Layout table for investigator information
Principal Investigator: Ehtisham Mahmud, MD University of California, San Diego
Additional Information:

Layout table for additonal information
Responsible Party: Corindus Inc. Identifier: NCT03278301    
Other Study ID Numbers: 2017-001
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases