PRECISION GRX Post-Market Study - Japan

A Post-Market Study in Japan for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 242

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Fukuoka City, Fukuoka, Japan, 814-0001
      • Fukuoka Sanno Hospital
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Hokkaido
    • Nayoro, Hokkaido, Japan, 096-8511
      • Nayoro City General Hospital
  • Iwate
    • Morioka, Iwate, Japan, 020-0023
      • Iwate University Hospital
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Tokai University Hospital
  • Ohashi Meguro-ku
    • Tokyo, Ohashi Meguro-ku, Japan, 153-0044
      • Toho University Ohashi Medical Center
  • Tochigi
    • Mibu, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital
  • Tokyo
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with coronary artery disease and with a clinical indication for PCI.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual stenosis in the lesion(s) treated	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).	Through end of subject's participation in the study, an average of up to 3 days.
Technical Success	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.	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	During procedure
PCI Procedure Time	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.	During procedure
Major adverse cardiac events (MACE)	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.	Through end of subject's participation in the study, an average of up to 3 days.
IVUS/OCT/IVUS-OCT Time (if used)	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.	During procedure
Fluoroscopy Time	Total fluoroscopy utilized during the procedure as recorded by an Imaging System.	During procedure
Patient Radiation Exposure	DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.	During procedure
Operator Radiation Exposure	Cumulative dose the physician receives as recorded from electronic pocket dosemeter during procedure.	During procedure

Collaborators and Investigators

• Sponsor: Corindus Inc.
• Collaborators: Japan Medicalnext, Co
• Investigators: Principal Investigator: Masato Nakamura, MD, Division of Cardiovascular Medicine, Professor Toho University Ohashi Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2019
• Primary Completion (ACTUAL): October 9, 2020
• Study Completion (ACTUAL): October 9, 2020

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (ACTUAL): March 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 104-08185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes