PRECISION GRX Post-Market Study - Japan

Siemens Healthineers Endovascular Robotics, Inc.242 enrolled

Overview

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.

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

242

Conditions

Coronary Artery Disease

Interventions

Robotic-assisted PCIDEVICE

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (8)

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Nayoro City General Hospital

Nayoro, Hokkaido, Japan

Iwate University Hospital

Morioka, Iwate, Japan

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: During procedure

Secondary Outcomes

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.

Time frame: Through end of subject's participation in the study, an average of up to 3 days.

Overall Procedure Time

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

Time frame: During procedure

PCI Procedure Time

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

Time frame: During procedure

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.

Time frame: During procedure

Data from ClinicalTrials.gov

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