Trial Outcomes & Findings for The ROB-OSTIAL Study (NCT NCT05634538)
NCT ID: NCT05634538
Last Updated: 2025-06-04
Results Overview
Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS)
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
Measured at end of procedure
Results posted on
2025-06-04
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The ROB-OSTIAL Study
Baseline characteristics by cohort
| Measure |
Robotic-assisted PCI With Corpath GRX® System
n=1 Participants
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).
|
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.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Canadian Cardiovascular Society (CCS) Angina Grade
|
3 units on a scale
n=5 Participants
|
—
|
3 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at end of procedurePopulation: One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy. No IVUS information collected.
Procedure-dependent geographic miss in millimeters (mm) obtained using intravascular ultrasound (IVUS)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at end of procedurePopulation: One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy. No IVUS information collected.
Distance from most proximal stent strut and coronary ostium (mm), as assessed by IVUS
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at discharge or 72 hours, whichever comes firstPopulation: Analysis population of the one subject enrolled and randomized.
Outcome measures
| Measure |
Robotic-assisted PCI With Corpath GRX® System
n=1 Participants
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).
|
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.
|
|---|---|---|
|
Comparison of Participants With In-hospital Major Cardiovascular Events
|
0 Adverse Events
|
—
|
SECONDARY outcome
Timeframe: Measured at end of procedurePopulation: One subject was enrolled and randomized, but was not treated per protocol due to tortuous vessel anatomy.
Defined as the duration from when the sheath is inserted until it is removed
Outcome measures
| Measure |
Robotic-assisted PCI With Corpath GRX® System
n=1 Participants
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).
|
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.
|
|---|---|---|
|
Procedural Duration
|
75 minutes
|
—
|
SECONDARY outcome
Timeframe: Measured at 1 monthPopulation: 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.
Outcome measures
Outcome data not reported
Adverse Events
Robotic-assisted PCI With Corpath GRX® System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard PCI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60