An interventional study of Robotic-assisted PCI with Corpath GRX® System and Standard PCI in Coronary Artery Disease, sponsored by Corindus Inc.. Terminated at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Corindus Inc. · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Percutaneous coronary intervention (PCI) using the Corpath GRX System.
Device: Robotic-assisted PCI with Corpath GRX® System
Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance.
Procedure: Standard PCI
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).
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.
Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment
Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS)
Time frame: Measured at end of procedure
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
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
Defined as the duration from when the sheath is inserted until it is removed
Time frame: Measured at end of procedure
Major Adverse Cardiovascular Events at 1 Month Follow-up
Time frame: Measured at 1 month
| Milestone | Robotic-assisted PCI With Corpath GRX® System | Standard PCI |
|---|---|---|
| Started | 1 | 0 |
| Completed | 0 | 0 |
| Not completed | 1 | 0 |
Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS)
No measurements were reported for this outcome.
Distance from most proximal stent strut and coronary ostium (mm), as assessed by IVUS
No measurements were reported for this outcome.
| Adverse Events | Robotic-assisted PCI With Corpath GRX® System | Standard PCI |
|---|---|---|
| Comparison of Participants With In-hospital Major Cardiovascular Events | 0 | — |
Defined as the duration from when the sheath is inserted until it is removed
| minutes | Robotic-assisted PCI With Corpath GRX® System | Standard PCI |
|---|---|---|
| Procedural Duration | 75 | — |
No measurements were reported for this outcome.
Collected over Adverse event data was ascertained on the the day of the one subject enrollment. After the subject was unable to undergo the study treatment per protocol the study was discontinued due to Sponsor business decision and therefore no additional adverse event data was collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Robotic-assisted PCI With Corpath GRX® System | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Standard PCI | — | — | — |
One subject was enrolled and randomized to Robotic-assisted PCI with Corpath GRX® System, however they were withdrawn before they could be treated with the CorPath GRX due to tortuous vessel anatomy. The study was then closed and no other subjects were enrolled.
| Age, Customized(Participants) | Robotic-assisted PCI With Corpath GRX® System | Standard PCI | Total |
|---|---|---|---|
| Count of participants | 1 | — | 1 |
| Sex: Female, Male(Participants) | Robotic-assisted PCI With Corpath GRX® System | Standard PCI | Total |
|---|---|---|---|
| Female | 1 | — | 1 |
| Male | 0 | — | 0 |
| Ethnicity (NIH/OMB)(Participants) | Robotic-assisted PCI With Corpath GRX® System | Standard PCI | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 1 | — | 1 |
| Unknown or Not Reported | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Robotic-assisted PCI With Corpath GRX® System | Standard PCI | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 0 | — | 0 |
| White | 1 | — | 1 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 0 | — | 0 |
| Region of Enrollment(participants) | Robotic-assisted PCI With Corpath GRX® System | Standard PCI | Total |
|---|---|---|---|
| Italy | 1 | — | 1 |
| Canadian Cardiovascular Society (CCS) Angina Grade(units on a scale) | Robotic-assisted PCI With Corpath GRX® System | Standard PCI | Total |
|---|---|---|---|
| Number | 3 | — | 3 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Corindus Inc.