ROVER: Registry of the Magellan Robotic System

Sponsor

Hansen Medical (Industry)

Overall Status

Terminated

CT.gov ID

NCT01984437

Collaborator

(none)

348

Enrollment

Locations

Duration (Months)

49.7

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Disease

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

348 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Robotic Vascular and Endovascular Registry (ROVER)

Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Outcome Measures

Primary Outcome Measures

Effectiveness [14 days post procedure]
Consistent manual delivery of therapeutic devices to the target vessel area in the peripheral vasculature by the physician.
Safety [14 days post procedure]
Incidence and description of device-related (Magellan Robotic System only) adverse events through the follow up period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be at least 18 years of age;
Able and willing to provide written informed consent;
Eligible for minimally invasive or endovascular treatment in the peripheral vasculature;
Not participating in an investigational study involving the peripheral vasculature.

Exclusion Criteria:

Disease targeted for treatment in the coronary vasculature or intra-cerebral vasculature;
Vasculature that cannot accommodate the Magellan™ Robotic Catheter or required accessories;
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;
An endovascular approach to the treatment of peripheral vasculature disease is contraindicated.
Patients who are prisoners.
Patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide informed consent, or deemed unreliable or unstable by the investigator.
Patients with a cognitive impairment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck Medical Center of USC	Los Angeles	California	United States	90033
2	Miami Cardiac & Vascular Institute	Miami	Florida	United States	33176
3	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
4	Miami Valley Hospital	Dayton	Ohio	United States	45409
5	The Methodist Hospital	Houston	Texas	United States	77030
6	University Hospital of Strasbourg	Strasbourg		France
7	Herz- und Gefäßzentrum Bad Bevensen	Bad Bevensen		Germany	29549