Registry of the Magellan Robotic System

Stopped early

Conditions studied: Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT01984437

Run by

Hansen Medical

People needed

348

Starts

2013-11-01

Expected to finish

2016-08-01

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Keck Medical Center of USC — Los Angeles, California, United States
• Miami Cardiac & Vascular Institute — Miami, Florida, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• Miami Valley Hospital — Dayton, Ohio, United States
• The Methodist Hospital — Houston, Texas, United States
• University Hospital of Strasbourg — Strasbourg, France
• Herz- und Gefäßzentrum Bad Bevensen — Bad Bevensen, Germany

Full record on ClinicalTrials.gov

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