Coronary Artery Disease
Conditions
Keywords
Ostial Lesion, Robotic-assisted PCI, PCI
Brief 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. 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.
Interventions
DEVICERobotic-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).
PROCEDUREStandard 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.
Sponsors
Corindus Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Full Ostial Coverage at Angiographic and IVUS Assessment | Measured at end of procedure | Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distance From Most Proximal Stent Strut and Coronary Ostium (mm), as Assessed by IVUS | Measured at end of procedure | Distance from most proximal stent strut and coronary ostium (mm), as assessed by IVUS |
| Comparison of Participants With In-hospital Major Cardiovascular Events | Measured at discharge or 72 hours, whichever comes first | — |
| Procedural Duration | Measured at end of procedure | Defined as the duration from when the sheath is inserted until it is removed |
| Major Adverse Cardiovascular Events at 1 Month Follow-up | Measured at 1 month | — |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 1 |
| 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 |
| Total | 1 |
Baseline characteristics
| Characteristic | Robotic-assisted PCI With Corpath GRX® System | Total |
|---|---|---|
| Age, Customized | 1 Participants | 1 Participants |
| Canadian Cardiovascular Society (CCS) Angina Grade | 3 units on a scale | 3 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment Italy | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
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
Population: One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy. No IVUS information collected.
Secondary
Comparison of Participants With In-hospital Major Cardiovascular Events
Time frame: Measured at discharge or 72 hours, whichever comes first
Population: Analysis population of the one subject enrolled and randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robotic-assisted PCI With Corpath GRX® System | Comparison of Participants With In-hospital Major Cardiovascular Events | 0 Adverse Events |
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
Time frame: Measured at end of procedure
Population: One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy. No IVUS information collected.
Secondary
Major Adverse Cardiovascular Events at 1 Month Follow-up
Time frame: Measured at 1 month
Population: 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.
Secondary
Procedural Duration
Defined as the duration from when the sheath is inserted until it is removed
Time frame: Measured at end of procedure
Population: One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Robotic-assisted PCI With Corpath GRX® System | Procedural Duration | 75 minutes |