Peripheral Arterial Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.
Detailed description
This is a prospective, single-arm, single center, non-randomized feasibility study of the CorPath 200 System to examine its performance during complete interventions (DCB, Stenting) of the femoropopliteal arteries and patient outcomes at 30 days.
Interventions
DEVICERobotic-assisted peripheral vascular intervention
Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
Sponsors
Corindus Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria * At least 18 years of age; * Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in the femoropopliteal arteries; and * The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent. Angiographic Inclusion Criteria Femoropopliteal artery lesion(s) with stenosis (\>50%) or occlusion of up to 120 mm in length as determined by imaging (MRA or Angio) prior to index interventional procedure.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | 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). |
| Adverse Events | Procedure | No device-related serious adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operator Radiation Exposure Dose | Procedure | Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters |
| Patient Radiation Exposure Dose | Procedure | Patient Radiation Dose-area-product (DAP) |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Robotic-assisted PVI Robotic-assisted peripheral vascular intervention: Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Robotic-assisted PVI |
|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment Austria | 20 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Adverse Events
No device-related serious adverse events.
Time frame: Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic-assisted PVI | Adverse Events | 0 Participants |
Primary
Clinical Success
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).
Time frame: 72 hours or hospital discharge, whichever comes first.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Robotic-assisted PVI | Clinical Success | 20 Participants |
Secondary
Operator Radiation Exposure Dose
Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters
Time frame: Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic-assisted PVI | Operator Radiation Exposure Dose | 1.9 μSv | Standard Deviation 2.9 |
Secondary
Patient Radiation Exposure Dose
Patient Radiation Dose-area-product (DAP)
Time frame: Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic-assisted PVI | Patient Radiation Exposure Dose | 566.7 Gy•m^2 | Standard Deviation 391.5 |