Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System

The purpose of this prospective study is to gather procedural use and safety data on the initial use of the Magellan Robotic System with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver This study will focus on, but not be limited to, endovascular embolization procedures in the peripheral vascular, for example, embolization of the splenic and hepatic arteries, uterine arterial embolization (UAE), prostatic arterial embolization (PAE), and trans-arterial chemoembolization (TACE).

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

Study Overview

• Status: Terminated
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: Magellan Robotic 6 Fr Catheter

Detailed Description

The primary objectives of this study are to evaluate the safety and clinical performance of the Magellan Robotic System with the 6 Fr catheter, Vascular Accessories 6 Fr and Microcatheter Driver in patients who are indicated for an embolization procedure or other endovascular procedure in the peripheral vasculature.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hopital Europeen Georges Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A subject must be a candidate for an embolization procedure or other endovascular procedure in the peripheral vasculature, meet all inclusion and no exclusion criteria, and be willing to comply with all protocol testing and follow-up.

Description

Inclusion Criteria:

• At least 18 years of age
• Able and willing to provide written informed consent
• Eligible for an embolization procedure or other endovascular procedure in the peripheral vasculature
• Not participating in an investigational study involving the peripheral vasculature

Exclusion Criteria:

• Vasculature 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
• Sepsis
• Major coagulation abnormalities
• Presence of significant co-morbid illness that contraindicates surgery or an interventional radiological procedure
• Unmanageable contrast agent hypersensitivity
• Patients who are prisoners
• Patients who are mentally incapacitated, e.g., comatose, unresponsive, cannot provide informed consent, or are deemed unreliable or unstable by the investigator or with a cognitive impairment
• Pregnant or breastfeeding

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Safety and Clinical Performance of the Magellan Robotic system with the 6 Fr Catheter. (incidence and description of reported Magellan System device related or contributed adverse events and device deficiencies)	The primary performance endpoint is device success defined as successful cannulation of the target blood vessel with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver on the first attempt, then accurate delivery of therapy. The primary safety endpoint is the incidence and description of reported Magellan System device related or contributed adverse events and device deficiencies through the study period.	2 Days
Device success (Successful cannulation of the target blood vessel with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver on the first attempt, the accurate delivery of Therapy)	Successful cannulation of the target blood vessel with the Magellan Robotic Catheter 6 Fr, Vascular Accessories 6 Fr and Microcatheter Driver on the first attempt, the accurate delivery of Therapy	2 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participation with Adverse Events	To evaluate use of the leader of Microcatheter as primary device for deliver of the therapy	30 days

Collaborators and Investigators

• Sponsor: Hansen Medical
• Investigators: Study Director: Brenda Cayme, RN, BSN, Hansen Medical Inc

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: HMP 021 Embolization