Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Corindus Inc.
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Device Technical Success
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •General Inclusion
- •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 iliac and/or superficial femoral arteries;
- •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
- •Failure/inability/unwillingness to provide informed consent;
- •Target vessel has been previously treated with bypass;
- •Has an abdominal aortic aneurysm contiguous with the iliac artery target lesion;
- •Has contraindication to anticoagulation;
- •Has bleeding or a hypercoagulability disorder;
- •Thrombocytopenia;
- •Elevated international normalized ratio (>1.5);
- •Elevated serum creatinine (≥2.5 mg/dL);
- •Active infection;
- •Contraindication to contrast; or
- •Enrolled in concurrent clinical study.
- •Angiographic Exclusion
- •Target vessel:
- •shows evidence of previous dissection or perforation, or
- •has adjacent acute thrombus;
- •Lesion is highly calcified;
- •Lesion requires use of any atherectomy device during the procedure;
- •Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.
Arms & Interventions
CorPath 200 System
CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention.
Intervention: CorPath 200 System (Device)
Outcomes
Primary Outcomes
Device Technical Success
Time Frame: Procedure
Number of lesions for which there was technical success" as accurate and appropriate.
Adverse Events
Time Frame: Procedure
No device-related serious adverse events during the procedure.
Secondary Outcomes
- Clinical Procedural Success(24-hours)
- Total Procedure Time(Procedure)
- Fluoroscopy Time(Procedure)
- Contrast Volume(Procedure)
- Interventional Procedure Time(Procedure)