NCT01984437

Registry of the Magellan Robotic System

The Robotic Vascular and Endovascular Registry (ROVER)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 348 (actual)
• Sponsor: Hansen Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Peripheral Vascular Disease

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2013-11-14
• Last updated: 2018-03-01

Locations

7 sites across 3 countries: United States, France, Germany