Trial Outcomes & Findings for Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease (NCT NCT02371785)

Results Overview

Number of lesions for which there was technical success" as accurate and appropriate.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Procedure

Results posted on

2019-03-19

Participant Flow

During February - April 2015 period 20 participants were enrolled in the RAPID study at one (1) clinical site.

Participant milestones

Participant milestones
Measure	CorPath 200 System CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Overall Study STARTED	20
Overall Study COMPLETED	20
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

Baseline characteristics by cohort
Measure	Baseline Demographics n=20 Participants Baseline measures for the treated subjects.
Age, Continuous	65.5 years STANDARD_DEVIATION 9.3 • n=20 Participants
Sex: Female, Male Female	6 Participants n=20 Participants
Sex: Female, Male Male	14 Participants n=20 Participants

PRIMARY outcome

Timeframe: Procedure

Population: 29 lesions treated in 20 subjects.

Number of lesions for which there was technical success" as accurate and appropriate.

Outcome measures

Outcome measures
Measure	CorPath 200 System n=29 lesions CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Device Technical Success	29 lesions

PRIMARY outcome

Timeframe: Procedure

Population: Device-related events that occured in subjects treated.

No device-related serious adverse events during the procedure.

Outcome measures

Outcome measures
Measure	CorPath 200 System n=20 Participants CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Adverse Events	0 Participants

SECONDARY outcome

Timeframe: 24-hours

Population: Achievement of \<50% residual stenosis in all robotic system treated lesions at the completion of the interventional procedure without an unplanned switch to the manual procedure in the absence of device-related serious adverse events.

Defined as \<50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure (without an unplanned switch to the manual procedure) in the absence of device-related SAE, either within twenty-four (24) hours of the procedure or prior to hospital discharge, whichever occurs first.

Outcome measures

Outcome measures
Measure	CorPath 200 System n=20 Participants CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Clinical Procedural Success	20 participants

SECONDARY outcome

Timeframe: Procedure

Population: Procedure time for subjects measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

As recorded by an X-ray system utilized during the procedure.

Outcome measures

Outcome measures
Measure	CorPath 200 System n=20 Participants CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Fluoroscopy Time	6.8 min Standard Error 3.4

SECONDARY outcome

Timeframe: Procedure

Population: Total amount of contrast used during CorPath procedure for subjects.

Total amount of contrast used during CorPath procedure.

Outcome measures

Outcome measures
Measure	CorPath 200 System n=20 Participants CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Contrast Volume	73.3 ml Standard Error 9.2

SECONDARY outcome

Timeframe: Procedure

Population: Total procedure time for subjects.

Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).

Outcome measures

Outcome measures
Measure	CorPath 200 System n=20 Participants CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Total Procedure Time	45.5 min Standard Deviation 6.2

SECONDARY outcome

Timeframe: Procedure

Population: Interventional procedure time for subjects.

Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

Outcome measures

Outcome measures
Measure	CorPath 200 System n=20 Participants CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention. CorPath 200 System: Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
Interventional Procedure Time	23.4 min Standard Deviation 14.0

Adverse Events

Device-related Periprocedural Event

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

Vice President, Clinical and Regulatory Affairs

Corindus Vascular Robotics

Phone: 260-615-8892

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place