Coronary Artery DiseaseNCT05634538
The ROB-OSTIAL Study
A study testing Robotic-assisted PCI with Corpath GRX® System and Standard PCI in people with Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Italy.
Trial summary
The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Robotic-assisted PCI with Corpath GRX® System and Standard PCI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteItaly
- Study dates
- 30 Mar 2023to 8 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or nonpregnant female aged ≥18 years
- Coronary OSTIAL lesion suitable for percutaneous coronary intervention (PCI)
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Who cannot join
- Cardiogenic shock or hemodynamic instability requiring support.
- ST-elevation myocardial infarction.
- Ongoing acute renal failure.
- In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status and/or anatomic characteristics
- More than one lesion to be treated
- Ostial left main disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotically Assisted PCI in Ostial Lesions
The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions.
CorPath GRX System (the Device) is a robotic-like device that is cleared for the remote delivery and control of heart catheterization devices. It helps doctors insert and move heart catheters (a thin, flexible tube) and similar types of devices inside patients blood vessels to treat the blockage in their heart.
The results will help to evaluate whether procedures using the CorPath GRX result in more accurate stenting (placing of a tube to keep heart vessel open) compared to standard PCI.
Read the detailed description
To assess accuracy of robotic-assisted PCI in obtaining full ostial lesion coverage and minimal protrusion compared to standard PCI.
Robotically assisted PCI offers the opportunity of performing minimal device movements (up to a minimum of 1 mm) in a stable and reproducible setting. This feature may be of great help when dealing with ostial lesions, whose treatment requires a precise stent positioning to avoid strut protrusion but also geographic miss of the lesion. Robotic-assisted PCI for ostial lesions showed encouraging results in large observational registries, but no study compared this approach with standard PCI.
The aim is to perform a randomized (1:1) study comparing standard (n=33) and robotic-assisted PCI (n=33) in obtaining full lesion coverage when treating ostial lesions (ostial left main will be excluded).
Primary endpoint of the study will be full ostial coverage as assessed by IVUS imaging, while secondary endpoints will be procedural success, vessel damage and number of protruding struts in the donor vessel as assessed by IVUS imaging.
- Conditions
- Coronary Artery Disease
- Being tested
- Robotic-assisted PCI with Corpath GRX® System, Standard PCI
- Keywords
- Ostial Lesion, Robotic-assisted PCI, 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 PCI with Corpath GRX® SystemDevice
The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary interventions (PCI).
Standard PCIProcedure or surgery
Percutaneous coronary intervention (PCI) is a procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart. This arm will be completed without robotic assistance.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted PCI with Corpath GRX® System | Active comparator | Percutaneous coronary intervention (PCI) using the Corpath GRX System. Receives: Device: Robotic-assisted PCI with Corpath GRX® System |
| Standard PCI | Active comparator | Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance. Receives: Procedure: Standard PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment
Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS)
Measured: Measured at end of procedure
Secondary outcomes (4)
Distance From Most Proximal Stent Strut and Coronary Ostium (mm), as Assessed by IVUS
Distance from most proximal stent strut and coronary ostium (mm), as assessed by IVUS
Measured: Measured at end of procedure
Comparison of Participants With In-hospital Major Cardiovascular Events
Measured: Measured at discharge or 72 hours, whichever comes first
Procedural Duration
Defined as the duration from when the sheath is inserted until it is removed
Measured: Measured at end of procedure
Major Adverse Cardiovascular Events at 1 Month Follow-up
Measured: Measured at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start30 Mar 2023
- Primary completion8 May 2023
- Study completion8 May 2023
Why it stopped: Sponsor strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634538
- Sponsor's protocol ID
- 104-13191
- Status last verified
- May 2025
- First submitted
- 17 Nov 2022
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotically Assisted PCI in Ostial Lesions
- ClinicalTrials.gov ID
- NCT05634538
- Acronym / sponsor ID
- 104-13191
- Conditions
- Coronary Artery Disease
- Keywords
- Ostial Lesion, Robotic-assisted PCI, PCI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor strategic decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions.
CorPath GRX System (the Device) is a robotic-like device that is cleared for the remote delivery and control of heart catheterization devices. It helps doctors insert and move heart catheters (a thin, flexible tube) and similar types of devices inside patients blood vessels to treat the blockage in their heart.
The results will help to evaluate whether procedures using the CorPath GRX result in more accurate stenting (placing of a tube to keep heart vessel open) compared to standard PCI.
Detailed description
To assess accuracy of robotic-assisted PCI in obtaining full ostial lesion coverage and minimal protrusion compared to standard PCI.
Robotically assisted PCI offers the opportunity of performing minimal device movements (up to a minimum of 1 mm) in a stable and reproducible setting. This feature may be of great help when dealing with ostial lesions, whose treatment requires a precise stent positioning to avoid strut protrusion but also geographic miss of the lesion. Robotic-assisted PCI for ostial lesions showed encouraging results in large observational registries, but no study compared this approach with standard PCI.
The aim is to perform a randomized (1:1) study comparing standard (n=33) and robotic-assisted PCI (n=33) in obtaining full lesion coverage when treating ostial lesions (ostial left main will be excluded).
Primary endpoint of the study will be full ostial coverage as assessed by IVUS imaging, while secondary endpoints will be procedural success, vessel damage and number of protruding struts in the donor vessel as assessed by IVUS imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted PCI with Corpath GRX® System | Active comparator | Device: Robotic-assisted PCI with Corpath GRX® SystemPercutaneous coronary intervention (PCI) using the Corpath GRX System. |
| Standard PCI | Active comparator | Procedure: Standard PCIPercutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or nonpregnant female aged ≥18 years
- Coronary OSTIAL lesion suitable for percutaneous coronary intervention (PCI)
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Key exclusion criteria (6 listed)
- Cardiogenic shock or hemodynamic instability requiring support.
- ST-elevation myocardial infarction.
- Ongoing acute renal failure.
- In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status and/or anatomic characteristics
- More than one lesion to be treated
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 PCI with Corpath GRX® SystemThe CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary interventions (PCI). | Device | Robotic-assisted PCI with Corpath GRX® System |
| Standard PCIPercutaneous coronary intervention (PCI) is a procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart. This arm will be completed without robotic assistance. | Procedure or surgery | Standard PCI |
Primary outcome
Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment
Time frame: Measured at end of procedure
Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS)
4 secondary outcomes
Distance From Most Proximal Stent Strut and Coronary Ostium (mm), as Assessed by IVUS
Time frame: Measured at end of procedure
Comparison of Participants With In-hospital Major Cardiovascular Events
Time frame: Measured at discharge or 72 hours, whichever comes first
Procedural Duration
Time frame: Measured at end of procedure
Major Adverse Cardiovascular Events at 1 Month Follow-up
Time frame: Measured at 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted PCI with Corpath GRX® System and Standard PCI in people with Coronary Artery Disease, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in Italy.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment (time frame: Measured at end of procedure). 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 4 Jun 2025.