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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
Embolization Procedures in the Peripheral Vasculature Using the Magellan™ Robotic System

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: Magellan Robotic 6 Fr Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Magellan Robotic 6 Fr Catheter|The Hansen Medical Magellan™ Robotic Catheter 6 Fr (Magellan™)|

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 |