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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03870087
Other study ID # 104-08185
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2019
Est. completion date October 9, 2020

Study information

Verified date October 2020
Source Corindus Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date October 9, 2020
Est. primary completion date October 9, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Japan Fukuoka Sanno Hospital Fukuoka City Fukuoka
Japan Tokai University Hospital Isehara Kanagawa
Japan Kurume University Hospital Kurume Fukuoka
Japan Dokkyo Medical University Hospital Mibu Tochigi
Japan Iwate University Hospital Morioka Iwate
Japan Nayoro City General Hospital Nayoro Hokkaido
Japan Keio University Hospital Shinjuku-ku Tokyo
Japan Toho University Ohashi Medical Center Tokyo Ohashi Meguro-ku

Sponsors (2)

Lead Sponsor Collaborator
Corindus Inc. Japan Medicalnext, Co

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 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.
Secondary Overall Procedure Time Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. During procedure
Secondary PCI Procedure Time Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. During procedure
Secondary 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
Secondary Fluoroscopy Time Total fluoroscopy utilized during the procedure as recorded by an Imaging System. During procedure
Secondary Patient Radiation Exposure DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure. During procedure
Secondary Operator Radiation Exposure Cumulative dose the physician receives as recorded from electronic pocket dosemeter during procedure. During procedure
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