Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Interventions: Device: Robotic-assisted peripheral vascular intervention

Registration Number: NCT02742077

Lead Sponsor: Corindus Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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 Exclusion Criteria

If any of the following criteria are met, the subject cannot be enrolled in this study:

Failure/inability/unwillingness to provide informed consent;
Target vessel has been previously treated with bypass; or
Enrolled in concurrent clinical study.

Angiographic Exclusion Criteria

• Target vessel:

Shows evidence of previous dissection or perforation, or
Has adjacent acute thrombus; or
Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic-assisted PVI	Robotic-assisted peripheral vascular intervention	Robotic-assisted peripheral vascular intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)