Peripheral Vascular Disease
Conditions
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.
Interventions
DEVICEMagellan Robotic 6 Fr Catheter
The Hansen Medical Magellan™ Robotic Catheter 6 Fr (Magellan™)
Sponsors
Hansen Medical
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 2 Days | 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. |
| 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) | 2 Days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participation with Adverse Events | 30 days | To evaluate use of the leader of Microcatheter as primary device for deliver of the therapy |
Countries
France
Outcome results
None listed