Phase
Condition
Hepatic Fibrosis
Skin Wounds
Liver Disorders
Treatment
Cera™ Vascular Plug System
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18 to 85;
Life expectancy > 1 year;
Require arterial or venous embolization in the peripheral vasculature;
Target embolization site(s) allow for safe insertion of the delivery catheter;
Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-relatedactivities commencement;
Willing and able to comply with protocol requirements, including all study visitsand procedures.
Exclusion
Exclusion Criteria:
The subject is pregnant or plan to be pregnant or breast feeding;
The subject has a known allergy or hypersensitivity to any of the device materialsincluding: nickel, stainless steel, polytetrafluoroethylene and titanium nitride;
The subject has a known allergy or hypersensitivity to contrast agent;
The subject has uncorrectable coagulopathy;
The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors,factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, duringand/or after treatment with the study device, which, in the opinion of theInvestigator, would clinically interfere with the study endpoints
The subject has an unresolved systemic infection;
Subject who cannot tolerate general or local anesthesia;
The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome),arteritis (e.g. Takayasu's Disease) or another circulatory disorder;
The subject is participating in other drug or medical device clinical trials;
Any condition (medical or anatomic) making the subject not suitable fortranscatheter embolotherapy according to the opinion of the investigator.
Study Design
Study Description
Connect with a study center
IRCCS Ospedale San Raffaele
Milan,
ItalyActive - Recruiting
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