An observational study in Aneurysm, Endoleak and Pulmonary Arteriovenous Malformation, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Recruiting at 9 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · Observational
The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to:
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.
29 studies on the registry are indexed under Endoleak; 6 are open to participants now.
This study's planned enrollment of 132 is above the median of 48 across 12 observational studies indexed under Endoleak.
Browse Endoleak studies →Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
Compared within Endoleak, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Aneurysm. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients who need arterial or venous embolization in the peripheral vasculature.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who need arterial or venous embolization in the peripheral vasculature.
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.
Technical success
Complete occlusion of the target embolization site at the time of the procedure. A target embolization site is considered completely occluded if angiography showed no residual flow.
Time frame: at procedure
Incidence of clinically relevant recanalization
Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention.
Time frame: at 3 months, 6 months, and 12 months post-procedure
Incidence of clinically relevant migration
Clinically relevant migration is defined as migration of the study device from the target embolization site that requires a re-intervention.
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
Device deficiency means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer.
Time frame: from attempted procedure to 12 months post-procedure
Time to occlusion
Defined as the time from the device placement to complete occlusion of the target embolization sites.
Time frame: at procedure
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2027, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
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