Trial Outcomes & Findings for Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II (NCT NCT02742077)

NCT ID: NCT02742077

Last Updated: 2020-11-04

Results Overview

Defined as \<50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 72 hours or hospital discharge, whichever comes first.
• Results posted on: 2020-11-04

Participant Flow

Participant milestones

Measure	Robotic-assisted PVI Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II

Baseline characteristics by cohort

Measure	Robotic-assisted PVI n=20 Participants Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Age, Continuous	65.6 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment Austria	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours or hospital discharge, whichever comes first.

Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE).

Outcome measures

Measure	Robotic-assisted PVI n=20 Participants Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Clinical Success	20 Participants

PRIMARY outcome

Timeframe: Procedure

No device-related serious adverse events.

Outcome measures

Measure	Robotic-assisted PVI n=20 Participants Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Adverse Events	0 Participants

SECONDARY outcome

Timeframe: Procedure

Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters

Outcome measures

Measure	Robotic-assisted PVI n=20 Participants Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Operator Radiation Exposure Dose	1.9 μSv Standard Deviation 2.9

SECONDARY outcome

Timeframe: Procedure

Patient Radiation Dose-area-product (DAP)

Outcome measures

Measure	Robotic-assisted PVI n=20 Participants Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Patient Radiation Exposure Dose	566.7 Gy•m^2 Standard Deviation 391.5

Adverse Events

Robotic-assisted PVI

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Robotic-assisted PVI n=20 participants at risk Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Skin and subcutaneous tissue disorders Access-site Hematoma	15.0% 3/20 • Number of events 3

Additional Information

Clinical Research Manager

Corindus, Inc.

Phone: (757) 910-4818

Email: tina.ridgeway@corindus.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place