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. (part of Siemens Healthineers) · Not applicable, Interventional, and Treatment
Among 302 studies in Coronary Artery Disease with a site in Italy — 48 open to participants now, 71 under way, 7 of them phase 3. Coronary Artery Disease · Italy.
Among the 302 studies in Coronary Artery Disease with a site in Italy, this one is the 187th largest by enrollment of the 189 interventional ones that give a count, is one of 20 that started in 2023, is one of 81 with no phase, and was the 246th registered.
4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.
Browse Coronary Artery Disease studies →48 of the 302 studies in Coronary Artery Disease with a site in Italy are open now. Recruiting first, the newest first:
Centro Cardiologico Monzino · Sites in Italy
Ages 18+
IRCCS San Raffaele · Sites in Italy
Ages 18+
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Sites in Italy
Centro Cardiologico Monzino · Sites in Italy
Ages 18+
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Sites in Italy, Poland, Romania and 1 more country
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 588 Coronary Artery Disease studies recruiting now, 403 (69%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
302 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 13 · Phase 3 41 · Phase 4 57
First in 2000; this study’s year is marked. 20 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1 is below the median of 124 across 3,009 interventional studies indexed under Coronary Artery Disease.
Median enrollment 290 across the 189 interventional studies, 400 across the 113 observational. Of the 151 that completed or were terminated, 35 (23%) have results posted.
This tab as a report to print or save as PDF → With an account.
101 of 302 have an industry lead sponsor. The 10 most frequent:
This study is registered under Corindus Inc., one of the names counted as Siemens Healthineers. Under that name alone:
Corindus Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.
Siemens Healthineers has 8 studies filed under Coronary Artery Disease — fewer than ten, so there is no comparison to draw.
13 of the studies in Coronary Artery Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06410690Centro Cardiologico MonzinoTrustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS | 2026-11-30 |
| NCT04604782GE HealthcareA Study to Evaluate the Safety and Pharmacokinetics of Regadenoson in Pediatric Patients | 2026-12 |
| NCT06321757Fundación EPICPREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients | 2026-12-30 |
| NCT07817524Fondazione Policlinico Universitario Agostino Gemelli IRCCSClinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN) | 2026-12-31 |
| NCT07291609Azienda Ospedaliera "Sant'Andrea"Microplastics and Nanoplastics in Patients With Chronic Coronary Syndromes | 2026-12-31 |
Add all 13 to your calendar (.ics) → With an account.
Among the 302 studies in Coronary Artery Disease with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2023 to primary completion in May 2023, 1 month.
Results were first posted in Jun 2025, 2 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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