Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PRECISION GRX Post-Market Study - Japan

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.
 
ClinicalTrials.gov Identifier: NCT03870087
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Japan Medicalnext, Co
Information provided by (Responsible Party):
Corindus Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 in the first 231 patients treated with the CorPath device in Japan.

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 in Japan 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 242 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: A Post-Market Study in Japan for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
Actual Study Start Date : April 12, 2019
Actual Primary Completion Date : October 9, 2020
Actual Study Completion Date : October 9, 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Robotic PCI
All subjects treated with CorPath GRX during the PCI procedure.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Residual stenosis in the lesion(s) treated [ Time Frame: Through end of subject's participation in the study, an average of up to 3 days. ]
    Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the CorPath GRX System, without in-hospital major adverse cardiac events (MACE) as assessed by the Angiographic Core Laboratory (ACL).

  2. Technical Success [ Time Frame: During 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. Major adverse cardiac events (MACE) [ Time Frame: Through end of subject's participation in the study, an average of up to 3 days. ]
    MACE that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath GRX System.

  2. Overall Procedure Time [ Time Frame: During procedure ]
    Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

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

  4. IVUS/OCT/IVUS-OCT Time (if used) [ Time Frame: During procedure ]
    Defined as the total time measured from insertion of the imaging catheter [Intravascular Ultrasound (IVUS), Optical Coherence Tomography (OCT) or integrated IVUS-OCT (IVUS-OCT)] until the removal of the imaging catheter.

  5. Fluoroscopy Time [ Time Frame: During procedure ]
    Total fluoroscopy utilized during the procedure as recorded by an Imaging System.

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

  7. Operator Radiation Exposure [ Time Frame: During procedure ]
    Cumulative dose the physician receives as recorded from electronic pocket dosemeter during procedure.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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:   20 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:

  1. Age ≥ 20 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, unless the EC has waived informed consent.

Exclusion Criteria:

  1. Failure/inability/unwillingness to provide informed consent, unless the EC has waived informed consent; or
  2. The Investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03870087


Locations
Layout table for location information
Japan
Fukuoka Sanno Hospital
Fukuoka City, Fukuoka, Japan, 814-0001
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Nayoro City General Hospital
Nayoro, Hokkaido, Japan, 096-8511
Iwate University Hospital
Morioka, Iwate, Japan, 020-0023
Tokai University Hospital
Isehara, Kanagawa, Japan, 259-1193
Toho University Ohashi Medical Center
Tokyo, Ohashi Meguro-ku, Japan, 153-0044
Dokkyo Medical University Hospital
Mibu, Tochigi, Japan, 321-0293
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Sponsors and Collaborators
Corindus Inc.
Japan Medicalnext, Co
Investigators
Layout table for investigator information
Principal Investigator: Masato Nakamura, MD Division of Cardiovascular Medicine, Professor Toho University Ohashi Medical Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Corindus Inc.
ClinicalTrials.gov Identifier: NCT03870087    
Other Study ID Numbers: 104-08185
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 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: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases