Trial Outcomes & Findings for GRX With ReMOTE: First in Human in India (NCT NCT03705481)
NCT ID: NCT03705481
Last Updated: 2020-01-31
Results Overview
Defined as completing the robotic PCI entirely with the CorPath GRX POP System.
COMPLETED
NA
5 participants
Measured from guide catheter in time through procedure end time (or guide catheter out time).
2020-01-31
Participant Flow
Participant milestones
| Measure |
Remote Treatment of PCI.
5 sequential subjects presenting for remote PCI who have signed informed consent.
Remote treatment of PCI.: To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.
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|---|---|
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Overall Study
STARTED
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5
|
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Overall Study
COMPLETED
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5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Age at Time of Consent
n=5 Participants
Age at the time of consent for the subjects that had a CorPath robotic PCI procedure performed remotely.
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|---|---|
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Age, Continuous
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54 years
n=5 Participants
|
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Sex: Female, Male
Female
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2 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured from guide catheter in time through procedure end time (or guide catheter out time).Population: Number of participants that had a remote robotic assisted PCI without unplanned conversion to manual technique.
Defined as completing the robotic PCI entirely with the CorPath GRX POP System.
Outcome measures
| Measure |
Device Technical Success
n=5 Participants
Number of participants that had a successful completion of the ReMOTE robotic-assisted PCI absent unplanned conversion to manual.
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|---|---|
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Device Technical Success
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5 Participants
|
PRIMARY outcome
Timeframe: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.Population: Number of participants with an In-hospital MACE occurrence.
Recording any MACE event that occurred from the time the sheath was inserted through 48 hours post procedure or hospital discharge, whichever of the two occurred first.
Outcome measures
| Measure |
Device Technical Success
n=5 Participants
Number of participants that had a successful completion of the ReMOTE robotic-assisted PCI absent unplanned conversion to manual.
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|---|---|
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In-hospital MACE
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured from guide catheter in time through procedure end time (or guide catheter out time).Population: Number of participants with a residual stenosis less than 30% (visual estimate).
Number of patients with a residual stenosis (visual estimate, less than 30%) post PCI in the lesion(s) treated with the CorPath GRX POP System.
Outcome measures
| Measure |
Device Technical Success
n=5 Participants
Number of participants that had a successful completion of the ReMOTE robotic-assisted PCI absent unplanned conversion to manual.
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|---|---|
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Clinical Procedural Success
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5 Participants
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SECONDARY outcome
Timeframe: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.Population: Number of participants with a Serious Adverse Events (SAEs) from the start of the Re- MOTE CorPath procedure until the end of the study
Recording any SAE that occurred measured from the sheath insertion time through 48 hours post procedure or hospital discharge, whichever occurred first.
Outcome measures
| Measure |
Device Technical Success
n=5 Participants
Number of participants that had a successful completion of the ReMOTE robotic-assisted PCI absent unplanned conversion to manual.
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|---|---|
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All Serious Adverse Events
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0 Participants
|
Adverse Events
Remote Treatment of PCI.
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Van Vleet, VP Clinical and Regulatory Affairs
Corindus, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place