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

CorPath® 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Robotic-assisted peripheral vascular intervention

Detailed 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.

• 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 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.

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
Other: Robotic-assisted PVI; Robotic-assisted peripheral vascular intervention	Device: Robotic-assisted peripheral vascular intervention; Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Defined as <50% residual stenosis in all CorPath 200 System treated lesions at the completion of the interventional procedure in the absence of device-related serious adverse events (SAE).	72 hours or hospital discharge, whichever comes first.
Adverse Events	No device-related serious adverse events.	Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator Radiation Exposure Dose	Physician operator radiation exposure as recorded on personal Enterprise Dose Dashboard (EDD; Landauer) dosimeters	Procedure
Patient Radiation Exposure Dose	Patient Radiation Dose-area-product (DAP)	Procedure

Collaborators and Investigators

• Sponsor: Corindus Inc.
• Investigators: Principal Investigator: Marianne Brodmann, MD, Medizinische Universtität Graz

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED