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

Recruiting now

Conditions studied: Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension, Arteriovenous Fistula, Splenic Laceration

In brief

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

Key facts

Study ID

NCT06099015

Run by

Lifetech Scientific (Shenzhen) Co., Ltd.

People needed

132

Starts

2024-06-21

Expected to finish

2028-06-30

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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-related activities commencement;
• Willing and able to comply with protocol requirements, including all study visits and procedures.
• Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study.

You may not qualify if…

• 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 materials including: 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, during and/or after treatment with the study device, which, in the opinion of the Investigator, 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 for transcatheter embolotherapy according to the opinion of the investigator.

Where it is running

• Klinikum Bad Hersfeld GmbH — Bad Hersfeld, Germany (enrolling)
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (enrolling)
• IRCCS Ospedale San Raffaele — Milan, Italy (enrolling)
• A.O.U. Città della Salute e Della Scienza di Torino — Turin, Italy (enrolling)
• Ospedale di Circolo — Varese, Italy (enrolling)
• Adana City Hospital — Adana, Turkey (Türkiye) (enrolling)
• Ankara University Hospital — Ankara, Turkey (Türkiye) (enrolling)
• Bilkent City Hospital — Ankara, Turkey (Türkiye) (enrolling)
• Bilkent City Hospital — Ankara, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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