NCT03870087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 12, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

March 4, 2019

Last Update Submit

October 15, 2020

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Major adverse cardiac events (MACE)

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

  • Overall Procedure Time

    During procedure

  • PCI Procedure Time

    During procedure

  • IVUS/OCT/IVUS-OCT Time (if used)

    During procedure

  • Fluoroscopy Time

    During procedure

  • +2 more secondary outcomes

Study Arms (1)

Robotic PCI

All subjects treated with CorPath GRX during the PCI procedure.

Device: Robotic-assisted PCI

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.

Robotic PCI

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 20 years;
  • Patients with coronary artery disease with clinical indication for PCI;
  • Patient deemed appropriate for robotic-assisted PCI; and
  • 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.

You may not qualify if:

  • Failure/inability/unwillingness to provide informed consent, unless the EC has waived informed consent; or
  • The Investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Fukuoka Sanno Hospital

Fukuoka, Fukuoka, 814-0001, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Nayoro City General Hospital

Nayoro, Hokkaido, 096-8511, Japan

Location

Iwate University Hospital

Morioka, Iwate, 020-0023, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Toho University Ohashi Medical Center

Tokyo, Ohashi Meguro-ku, 153-0044, Japan

Location

Dokkyo Medical University Hospital

Mibu, Tochigi, 321-0293, Japan

Location

Keio University Hospital

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Masato Nakamura, MD

    Division of Cardiovascular Medicine, Professor Toho University Ohashi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 11, 2019

Study Start

April 12, 2019

Primary Completion

October 9, 2020

Study Completion

October 9, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

JP(8)