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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: CorPath 200 System

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • Medizinische Univeristät Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CorPath 200 System; CorPath 200 System for remote delivery and manipulation of guidewires and balloon catheters during percutaneous vascular intervention.	Device: CorPath 200 System; Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Fluoroscopy Time	As recorded by an X-ray system utilized during the procedure.	Procedure
Contrast Volume	Total amount of contrast used during CorPath procedure.	Procedure
Total Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until procedure complete (guide catheter removed).	Procedure
Interventional Procedure Time	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.	Procedure

Collaborators and Investigators

• Sponsor: Corindus Inc.
• Investigators: Principal Investigator: Marianne Brodmann, M.D., Medizinische Universität Graz

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2015
• Primary Completion (Actual): April 28, 2015
• Study Completion (Actual): May 22, 2015

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: February 25, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Claudication; Peripheral Arterial Disease; Critical Limb Ischemia; Percutaneous Vascular Intervention; Peripheral Vascular Intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2014-002 (Other Identifier: Barbara Ann Karmanos Cancer Institute)