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Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II

NCT ID: NCT02742077

Last Updated: 2020-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic-assisted PVI

Robotic-assisted peripheral vascular intervention

Group Type OTHER

Robotic-assisted peripheral vascular intervention

Intervention Type DEVICE

Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.

Interventions

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Robotic-assisted peripheral vascular intervention

Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.

Intervention Type DEVICE

Eligibility Criteria

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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.

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.


• 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corindus Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Brodmann, MD

Role: PRINCIPAL_INVESTIGATOR

Medizinische Universtität Graz

Locations

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Medizinische Univeristät Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2016-01

Identifier Type: -

Identifier Source: org_study_id