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Sponsor strategic decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic-assisted PCI with Corpath GRX® System | Active Comparator | Percutaneous coronary intervention (PCI) using the Corpath GRX System. |
|
| Standard PCI | Active Comparator | Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted PCI with Corpath GRX® System | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment | Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS) | Measured at end of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at end of procedure |
| Comparison of Participants With In-hospital Major Cardiovascular Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Cecilia Hospital | Cotignola | RA | 48033 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic-assisted PCI With Corpath GRX® System | Percutaneous coronary intervention (PCI) using the Corpath GRX System. Robotic-assisted PCI with Corpath GRX® System: 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). |
| FG001 | Standard PCI | Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance. Standard 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic-assisted PCI With Corpath GRX® System | Percutaneous coronary intervention (PCI) using the Corpath GRX System. Robotic-assisted PCI with Corpath GRX® System: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment | Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS) | One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy. No IVUS information collected. | Posted | Measured at end of procedure |
|
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.
The protocol utilized MEDDEV 2.7/3rev. 3 May 2015 ; ISO 14155:2011 for adverse event definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robotic-assisted PCI With Corpath GRX® System | Percutaneous coronary intervention (PCI) using the Corpath GRX System. Robotic-assisted PCI with Corpath GRX® System: 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Lord | Corindus | 617-943-5472 | alison.lord@siemens-healthineers.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 23, 2022 | Apr 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Standard PCI | Procedure | 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. |
|
| 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 at end of procedure |
| Major Adverse Cardiovascular Events at 1 Month Follow-up | Measured at 1 month |
| BG001 | Standard PCI | Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance. Standard 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Canadian Cardiovascular Society (CCS) Angina Grade | I:Ordinary physical activity (OPA) does not cause angina, such as walking/climbing stairs. Angina occurs with strenuous/rapid/prolonged exertion 2: Slight limitation of OPA. Angina occurs with quick/uphill walking, after meals, in cold/wind, under stress, or soon after waking. Walking >2 flat blocks & climbing >1 flight of stairs at a normal pace/conditions 3: Marked limitations of OPA. Angina occurs on walking 1-2 blocks on the level and climbing 1 flight of stairs in normal conditions/pace 4: Inability to carry on any physical activity without discomfort: angina may be present at rest | Number | units on a scale |
|
| Standard PCI |
Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance. Standard 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. |
|
| Secondary | 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 | One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy. No IVUS information collected. | Posted | Measured at end of procedure |
|
|
| Secondary | Comparison of Participants With In-hospital Major Cardiovascular Events | Analysis population of the one subject enrolled and randomized. | Posted | Number | Adverse Events | Measured at discharge or 72 hours, whichever comes first |
|
|
|
| Secondary | Procedural Duration | Defined as the duration from when the sheath is inserted until it is removed | One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy. | Posted | Number | minutes | Measured at end of procedure |
|
|
|
| Secondary | Major Adverse Cardiovascular Events at 1 Month Follow-up | One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy. Study was shut down and no further follow-up completed. | Posted | Measured at 1 month |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Standard PCI | Percutaneous coronary intervention (PCI) using manual techniques. This arm will be completed without robotic assistance. Standard 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |