Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

— RAPID  

Official title:

Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371785
• Other study ID #: 2014-002
• Status: Completed
• Phase: N/A
• Start date: February 3, 2015
• Est. completion date: May 22, 2015

Study information

• Verified date: March 2019
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 22, 2015
• Est. primary completion date: April 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• CorPath 200 System
Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).

Locations

Country	Name	City	State
Austria	Medizinische Univeristät Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Technical Success	Number of lesions for which there was technical success" as accurate and appropriate.	Procedure
Primary	Adverse Events	No device-related serious adverse events during the procedure.	Procedure
Secondary	Clinical Procedural Success	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.	24-hours
Secondary	Fluoroscopy Time	As recorded by an X-ray system utilized during the procedure.	Procedure
Secondary	Contrast Volume	Total amount of contrast used during CorPath procedure.	Procedure
Secondary	Total Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).	Procedure
Secondary	Interventional Procedure Time	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.	Procedure