Registry of the Magellan Robotic System

NCT01984437 | Terminated

• 1 other identifier: HMP020
• Study Type: observational
• Target: 348
• Locations: 3 countries
• Sites: 7

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.

Conditions

Peripheral Vascular Disease

Keywords

Vascular disease; Minimally invasive treatment; Endovascular treatment; Magellan; Robotic

Outcome Measures

Primary Outcomes (2)

• Effectiveness

  Consistent manual delivery of therapeutic devices to the target vessel area in the peripheral vasculature by the physician.

  14 days post procedure

• Safety

  Incidence and description of device-related (Magellan Robotic System only) adverse events through the follow up period.

  14 days post procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects must be diagnosed with vascular disease in the peripheral vasculature, meet all inclusion and no exclusion criteria, and be willing to comply with all protocol testing and follow-up.

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.

Sponsors & Collaborators

• Hansen Medical: lead

Study Sites (7)

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location

Miami Cardiac & Vascular Institute

Miami, Florida, 33176, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University Hospital of Strasbourg

Strasbourg, France

Location

Herz- und Gefäßzentrum Bad Bevensen

Bad Bevensen, 29549, Germany

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Jean Bismuth, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Brenda Cayme, RN, BSN

  Hansen Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 14, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 1, 2018

Record last verified: 2016-07

Locations

FR (1); US (5); DE (1)