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

Peripheral Vascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02369692
• Other study ID #: HMP 021 Embolization
• Status: Terminated
• Phase: N/A
• First received: February 6, 2015
• Last updated: February 27, 2018
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2015
• Source: Hansen Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Magellan Robotic 6 Fr Catheter
The Hansen Medical Magellan™ Robotic Catheter 6 Fr (Magellan™)

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hansen Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participation with Adverse Events	To evaluate use of the leader of Microcatheter as primary device for deliver of the therapy	30 days