Coronary Artery DiseaseNCT03870087
PRECISION GRX Post-Market Study - Japan
An observational study of Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 8 sites in Japan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Robotic-assisted PCI
- Type of treatment
- Medical device
- How many people
- 242 participants
- Where
- 8 sitesJapan
- Study dates
- 12 Apr 2019to 9 Oct 2020
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with coronary artery disease and with a clinical indication for PCI.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Fukuoka Sanno Hospital
Fukuoka, Fukuoka, 814-0001
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Kurume University Hospital
Kurume, Fukuoka, 830-0011
Dokkyo Medical University Hospital
Mibu, Tochigi, 321-0293
Iwate University Hospital
Morioka, Iwate, 020-0023
Nayoro City General Hospital
Nayoro, Hokkaido, 096-8511
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Toho University Ohashi Medical Center
Tokyo, Ohashi Meguro-ku, 153-0044
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Robotic-assisted PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic PCI | All subjects treated with CorPath GRX during the PCI procedure. Receives: Device: Robotic-assisted PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: During procedure
Secondary outcomes (7)
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.
Measured: 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.
Measured: During procedure
PCI Procedure Time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Measured: 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.
Measured: During procedure
Fluoroscopy Time
Total fluoroscopy utilized during the procedure as recorded by an Imaging System.
Measured: During procedure
Patient Radiation Exposure
DAP (dose-area-product) and cumulative dose/air kerma as recorded during the procedure.
Measured: During procedure
Operator Radiation Exposure
Cumulative dose the physician receives as recorded from electronic pocket dosemeter during procedure.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start12 Apr 2019
- Primary completion9 Oct 2020
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Japan Medicalnext, Co
- Responsible party
- Sponsor
- Investigators
- Masato Nakamura, MD, Principal investigator, Division of Cardiovascular Medicine, Professor Toho University Ohashi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870087
- Sponsor's protocol ID
- 104-08185
- Status last verified
- Oct 2020
- First submitted
- 4 Mar 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study in Japan for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT03870087
- Acronym / sponsor ID
- 104-08185
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Japan Medicalnext, Co
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic PCI | – | Device: Robotic-assisted PCIAll subjects treated with CorPath GRX during the PCI procedure. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with coronary artery disease and with a clinical indication for PCI.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic-assisted PCIThe 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. | Device | Robotic PCI |
Primary outcome
Residual stenosis in the lesion(s) treated
Time frame: Through end of subject's participation in the study, an average of up to 3 days.
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).
Technical Success
Time frame: During procedure
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.
7 secondary outcomes
Major adverse cardiac events (MACE)
Time frame: Through end of subject's participation in the study, an average of up to 3 days.
Overall Procedure Time
Time frame: During procedure
PCI Procedure Time
Time frame: During procedure
IVUS/OCT/IVUS-OCT Time (if used)
Time frame: During procedure
Fluoroscopy Time
Time frame: During procedure
Patient Radiation Exposure
Time frame: During procedure
Operator Radiation Exposure
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masato Nakamura, MD principal investigator
Division of Cardiovascular Medicine, Professor Toho University Ohashi Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual stenosis in the lesion(s) treated (time frame: Through end of subject's participation in the study, an average of up to 3 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.