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Recruiting NCT06099015

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

— Observational Aneurysm Endoleak Pulmonary Arteriovenous Malformation Portal Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cera™ Vascular Plug System.
Who it may be relevant to
Registry conditions: Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Italy, Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

Lifetech Cera™ Vascular Plug System is indicated for arterial and venous embolization in the peripheral vasculature. This study, planned under the MDR requirements, aims to confirm the safety and performance of the Lifetech Cera™ Vascular Plug System, identify previously unknown side-effects, monitor the identified side-effects (related to the procedures or to the medical devices), identify and analyse emergent risks. The Study intends to enroll 132 subjects. The estimated enrollment period is 1 year, and the expected duration of each subject's participation is 1 year (i.e., the follow-up period). Final report shall be completed in 2026.

Interventions

  • 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.

Primary outcome measures

  • Technical success [Time frame: at procedure]
Secondary outcome measures (6)
  • Incidence of clinically relevant recanalization [Time frame: at 3 months, 6 months, and 12 months post-procedure]
  • Incidence of clinically relevant migration [Time frame: at 3 months, 6 months, and 12 months post-procedure]
  • Incidence of device and/or procedure-related Adverse Events (AEs) [Time frame: from attempted procedure to 12 months post-procedure]
  • Incidence of device and/or procedure-related Serious Adverse Events (SAEs) [Time frame: from attempted procedure to 12 months post-procedure]
  • Incidence of device deficiencies [Time frame: from attempted procedure to 12 months post-procedure]
  • Time to occlusion [Time frame: at procedure]

Eligibility criteria

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-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.

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 4 centers
  • ASST Grande Ospedale Metropolitano Niguarda — Milan
  • IRCCS Ospedale San Raffaele — Milan
  • A.O.U. Città della Salute e Della Scienza di Torino — Turin
  • Ospedale di Circolo — Varese
Turkey (Türkiye) · 4 centers
  • Adana City Hospital — Adana
  • Ankara University Hospital — Ankara
  • Bilkent City Hospital — Ankara
  • Bilkent City Hospital — Ankara
Germany · 1 center
  • Klinikum Bad Hersfeld GmbH — Bad Hersfeld

Identifiers

NCT: NCT06099015 · LT-TS-22CE-04-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗