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Recruiting NCT06099015

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

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

Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

trial.available_in: БГ
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
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.
Who can participate
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.
Interventions
Cera™ Vascular Plug System
DEVICE
Locations 9
Germany (1)
Klinikum Bad Hersfeld GmbH
Bad Hersfeld
NOT_YET_RECRUITING
Italy (4)
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 (4)
Adana City Hospital
Adana
Ankara University Hospital
Ankara
Bilkent City Hospital
Ankara
Bilkent City Hospital
Ankara
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
21.06.2024
Completion date
01.12.2027
Registry ID
NCT06099015
Source
clinicaltrials.gov
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