Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II (RAPID II)

Corindus

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Device: Robotic-assisted peripheral vascular intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT02742077

2016-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.