Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGOBSERVATIONAL

Cera™ Vascular Plug System Post-Market Clinical Follow-Up

Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: * confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks

Who May Be Eligible (Plain English)

Who May Qualify: 1. Aged 18 to 85; 2. Life expectancy \> 1 year; 3. Require arterial or venous embolization in the peripheral vasculature; 4. Target embolization site(s) allow for safe insertion of the delivery catheter; 5. Voluntarily sign and date the willing to sign a consent form Form (ICF) prior to any study-related activities commencement; 6. Willing and able to comply with protocol requirements, including all study visits and procedures. Who Should NOT Join This Trial: 1. The subject is pregnant or plan to be pregnant or breast feeding; 2. The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride; 3. The subject has a known allergy or hypersensitivity to contrast agent; 4. The subject has uncorrectable coagulopathy; 5. The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints 6. The subject has an unresolved systemic infection; 7. Subject who cannot tolerate general or local anesthesia; 8. The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder; 9. The subject is participating in other drug or medical device clinical trials; 10. Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Aged 18 to 85; 2. Life expectancy \> 1 year; 3. Require arterial or venous embolization in the peripheral vasculature; 4. Target embolization site(s) allow for safe insertion of the delivery catheter; 5. Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-related activities commencement; 6. Willing and able to comply with protocol requirements, including all study visits and procedures. Exclusion Criteria: 1. The subject is pregnant or plan to be pregnant or breast feeding; 2. The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride; 3. The subject has a known allergy or hypersensitivity to contrast agent; 4. The subject has uncorrectable coagulopathy; 5. The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints 6. The subject has an unresolved systemic infection; 7. Subject who cannot tolerate general or local anesthesia; 8. The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder; 9. The subject is participating in other drug or medical device clinical trials; 10. Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.

Treatments Being Tested

DEVICE

Cera™ Vascular Plug System

The Cera™ Vascular Plug System is composed of Cera™ Vascular Plug and its accessory Introducer Kit. The Cera™ Vascular Plug is a self-expandable, cylindrical Ni-Ti wire mesh device.

Locations (4)

ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
A.O.U. Città della Salute e Della Scienza di Torino
Turin, Italy
Ospedale di Circolo
Varese, Italy