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PRECISION GRX Registry

Sponsor
Corindus Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03278301
Collaborator
(none)
952
Enrollment
20
Locations
29.3
Actual Duration (Months)
47.6
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
952 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
Actual Study Start Date :
Aug 27, 2017
Actual Primary Completion Date :
Feb 6, 2020
Actual Study Completion Date :
Feb 6, 2020

Outcome Measures

Primary Outcome Measures

  1. Clinical Success [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 [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 [Procedure]

    Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

  2. PCI Procedure Time [Procedure]

    Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

  3. Fluoroscopy Time [Procedure]

    Total Fluoroscopy Time during procedure will be captured.

  4. Patient Radiation Exposure [Procedure]

    DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UC San Diego Health Sulpizio Cardiovascular Center San Diego California United States 92037
2 MedStar Washington Hospital Center Washington District of Columbia United States 20010
3 Spectrum Health Hospitals Fred and Lena Meijer Heart Center Grand Rapids Michigan United States 49503
4 William Beaumont Hospital - Troy Troy Michigan United States 48085
5 St. Luke's Hospital of Kansas City Kansas City Missouri United States 64111
6 Montefiore Medical Center Bronx New York United States 10467
7 New York-Presbyterian Columbia University Medical Center New York New York United States 10032
8 WakeMed Raleigh Campus Raleigh North Carolina United States 27610
9 Einstein Medical Center Philadelphia Pennsylvania United States 19141
10 Wellspan York Hospital York Pennsylvania United States 17405
11 Jackson-Madison County General Hospital Jackson Tennessee United States 38301
12 Baylor Jack and Jane Hamilton Heart and Vascular Hospital Dallas Texas United States 75226
13 Baylor Scott and White All Saints Medical Center Fort Worth Texas United States 76104
14 Houston Methodist Hospital Houston Texas United States 77030
15 The Heart Hospital Baylor Plano Plano Texas United States 75093
16 University of Virginia Health System University Hospital Charlottesville Virginia United States 22903
17 University of Washington Medical Center Seattle Washington United States 98195
18 Albert Einstein Israelite Hospital São Paulo Sao Paulo Brazil 05652-900
19 Apex Heart Institute Ahmedabad Gujarat India 380059
20 Tan Tock Seng Hospital Singapore Singapore 308433

Sponsors and Collaborators

  • Corindus Inc.

Investigators

  • Principal Investigator: Ehtisham Mahmud, MD, University of California, San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Corindus Inc.
ClinicalTrials.gov Identifier:
NCT03278301
Other Study ID Numbers:
  • 2017-001
First Posted:
Sep 11, 2017
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Oct 19, 2020