Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

NCT ID: NCT02371785

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-03
• Study Completion Date: 2015-05-22

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CorPath 200 System

CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention.

Group Type: EXPERIMENTAL

CorPath 200 System

Intervention Type: DEVICE

Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).

Interventions

CorPath 200 System

Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corindus Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marianne Brodmann, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medizinische Universität Graz

Locations

Medizinische Univeristät Graz

Graz, , Austria

Countries

Austria

Other Identifiers

2014-002

Identifier Type: -

Identifier Source: org_study_id