Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Interventions: Device: CorPath 200 System

Registration Number: NCT02371785

Lead Sponsor: Corindus Inc.

Brief Summary: This study evaluates the performance of the CorPath 200 System to deliver guide wires and balloons to blockages in the arteries of the leg.

Detailed Description: The CorPath 200 System is currently marketed for remotely delivering guide wires, balloons and stents to blockages in the coronary arteries. This study will evaluate the feasibility of CorPath 200 System to deliver guide wires and balloons to blockages in non-coronary arteries.

Guide wires and balloons are delivered to blockages in the lower limbs manually by doctors.If this study shows that guide wires and balloons can be safely delivered to blockages in the lower limbs, then it will be an alternative for physicians.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

General Inclusion
1. At least 18 years of age;
2. Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in iliac and/or superficial femoral arteries;
3. The subject or the legally authorized representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.
Angiographic Inclusion

Presence of superficial femoral artery and/or iliac stenosis (>50%) or occlusion of up to 50 mm in length as determined by angiogram prior to index interventional procedure.

Exclusion Criteria

General Exclusion
1. Failure/inability/unwillingness to provide informed consent;
2. Target vessel has been previously treated with bypass;
3. Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion;
4. Has contraindication to anticoagulation;
5. Has bleeding or a hypercoagulability disorder;
6. Thrombocytopenia;
7. Elevated international normalized ratio (>1.5);
8. Elevated serum creatinine (≥2.5 mg/dL);
9. Active infection;
10. Contraindication to contrast; or
11. Enrolled in concurrent clinical study.
Angiographic Exclusion
1. Target vessel:
  1. shows evidence of previous dissection or perforation, or
  2. has adjacent acute thrombus;
2. Lesion is highly calcified;
3. Lesion requires use of any atherectomy device during the procedure;
4. 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
CorPath 200 System	CorPath 200 System	CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention.

Primary Outcome Measures

Name	Time	Method
Device Technical Success	Procedure	Number of lesions for which there was technical success" as accurate and appropriate.
Adverse Events	Procedure	No device-related serious adverse events during the procedure.

Secondary Outcome Measures

Name	Time	Method
Clinical Procedural Success	24-hours	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.
Total Procedure Time	Procedure	Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).
Fluoroscopy Time	Procedure	As recorded by an X-ray system utilized during the procedure.
Contrast Volume	Procedure	Total amount of contrast used during CorPath procedure.
Interventional Procedure Time	Procedure	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.