Clinical trial NCT03870087: PRECISION GRX Post-Market Study - Japan
Official title: A Post-Market Study in Japan for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
Collaborators: name: Japan Medicalnext, Co
First posted: 2019-03-11
Enrollment: 242
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with coronary artery disease and with a clinical indication for PCI.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Residual stenosis in the lesion(s) treated
timeFrame: Through end of subject's participation in the study, an average of up to 3 days.
measure: Technical Success
timeFrame: During procedure
Secondary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: Through end of subject's participation in the study, an average of up to 3 days.
measure: Overall Procedure Time
timeFrame: During procedure
measure: PCI Procedure Time
timeFrame: During procedure
measure: IVUS/OCT/IVUS-OCT Time (if used)
timeFrame: During procedure
measure: Fluoroscopy Time
timeFrame: During procedure
measure: Patient Radiation Exposure
timeFrame: During procedure
measure: Operator Radiation Exposure
timeFrame: During procedure
Other outcomes:
Locations:
city: Fukuoka City
country: Japan
facility: Fukuoka Sanno Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Nayoro
country: Japan
facility: Nayoro City General Hospital
state: Hokkaido
city: Morioka
country: Japan
facility: Iwate University Hospital
state: Iwate
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
state: Ohashi Meguro-ku
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
affiliation: Division of Cardiovascular Medicine, Professor Toho University Ohashi Medical Center
name: Masato Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
References: