Registry of the Magellan Robotic System



Status:Terminated
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:November 2013
End Date:August 2016

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The Robotic Vascular and Endovascular Registry (ROVER)

The purpose of the registry is to gather both retrospective and prospective case data on the
use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in
accordance with the approved intended use. For prospective cases, follow-up patient data will
be collected at 14 days (± 5 days) post procedure to assess treatment success, primary
patency of intended targeted vessel region, and adverse events.

The data will be analyzed for medical education, societal presentation, and/or publication by
the investigators.

Over the next 2+ years, physicians who meet the selection criteria will be invited to
participate in the registry.

The objectives of the study are to allow the physician to use the commercially available
Magellan Robotic System and Magellan Robotic Catheters to navigate to the treatment targets
in the peripheral vasculature to:

- Determine the number of endovascular procedures consecutively performed with the
Magellan Robotic System to navigate to treatment targets in the peripheral vasculature
and,

- Achieve stable and efficient system preparation and set-up times, navigation and
cannulation times of target vessels during endovascular procedures, and placement
of therapeutic equipment used to perform endovascular procedures.

- Achieve stable and reduced fluoroscopy time during the endovascular procedures.

- Determine the number of cases required to reach a "steady state," reduction or
predictable time in conducting peripheral interventional procedures using descriptive
(means, ranges) statistics to analyze the data.

Design

This is a prospective and retrospective, multi-center, single arm, non-blinded, sequentially
enrolling data collection activity (for which Hansen Medical is providing funding). Only
patients scheduled to undergo endovascular procedures using the Magellan Robotic System will
be approached for enrollment.

Methods

Registry procedures will be conducted in accordance with the labeled indication for use of
the Magellan™ Robotic System.

Prior to the physician participating in the registry and prior to subject enrollment, all
participating physicians will be required to complete Hansen Medical's Magellan Robotic
System training.

Participating registry sites must have a commercially available Magellan Robotic System for
the treatment of patients.

Data Management

Participating sites will be assigned a specific site numeric identification code by the
registry sponsor.

The information collected into the registry will be data related to the procedure in which
the Magellan System was used or planned to be used and may include patient follow-up data,
minimally 14 days(± 5 days)post procedure but also may include 30 day follow-up to assess for
the resolution of a procedural or post procedure adverse event.

The database will be a repository for the collected registry data and the data will be made
available (in extractable format) to the physician participants.

Adverse Events

The data submitted will be reviewed on a regular basis for safety issues and complaints.

Adverse events and/or complaints deemed reportable will be submitted to the appropriate
regulatory agency/agencies by Hansen Medical, Inc.

Inclusion Criteria:

1. Must be at least 18 years of age;

2. Able and willing to provide written informed consent;

3. Eligible for minimally invasive or endovascular treatment in the peripheral
vasculature;

4. Not participating in an investigational study involving the peripheral vasculature.

Exclusion Criteria:

1. Disease targeted for treatment in the coronary vasculature or intra-cerebral
vasculature;

2. Vasculature that cannot accommodate the Magellan™ Robotic Catheter or required
accessories;

3. The required delivery of therapeutic device(s) through the Magellan Robotic Catheter
in which the diameter for the therapeutic device(s) is/are incompatible with the
Magellan Robotic Catheter;

4. An endovascular approach to the treatment of peripheral vasculature disease is
contraindicated.

5. Patients who are prisoners.

6. Patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide
informed consent, or deemed unreliable or unstable by the investigator.

7. Patients with a cognitive impairment.
We found this trial at
6
sites
Cincinnati, Ohio 45220
Phone: 513-862-2877
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Phone: 937-208-4878
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Houston, Texas 77030
Phone: 713-441-6539
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Houston, TX
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Los Angeles, California 90033
Phone: 323-442-8176
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Los Angeles, CA
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Miami, Florida 33176
Phone: 786-596-6258
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Strasbourg,
Phone: 0369551682
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Strasbourg,
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