AneurysmNCT06099015
Cera™ Vascular Plug System Post-Market Clinical Follow-Up
An observational study of Aneurysm and Endoleak, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 9 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation
- What is being tested?
- Cera™ Vascular Plug System
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 21 Jun 2024to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who need arterial or venous embolization in the peripheral vasculature.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
Italy4 sites, 4 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan
Alberto Froio
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Andrea Kahlberg
- Recruiting
A.O.U. Città della Salute e Della Scienza di Torino
Turin
Floriana Nardelli
- Recruiting
Ospedale di Circolo
Varese
Federico Fontana
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Adana City Hospital
Adana
Ferid Cereb
- Recruiting
Ankara University Hospital
Ankara
Emre Celebioğlu
- Recruiting
Bilkent City Hospital
Ankara
Murat Canyigit
- Recruiting
Bilkent City Hospital
Ankara
Ibrahim Ece
Germany1 site, 1 recruiting
- Recruiting
Klinikum Bad Hersfeld GmbH
Bad Hersfeld
Ahmed Mashhour
About this study
Official title: Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study
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
Read the 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.
- Conditions
- Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension, Arteriovenous Fistula, Splenic Laceration
- Being tested
- Cera™ Vascular Plug System
- Keywords
- Lifetech, Cera Vascular Plug
- Medical subject headings
- Aneurysm, Endoleak, Pulmonary Arteriovenous Fistulas, Hypertension, Portal, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cera™ Vascular Plug SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Cera Vascular Plug Subjects | Patients who need arterial or venous embolization in the peripheral vasculature. Receives: Device: Cera™ Vascular Plug System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at procedure
Secondary outcomes (6)
Incidence of clinically relevant recanalization
Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention.
Measured: 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.
Measured: at 3 months, 6 months, and 12 months post-procedure
Incidence of device and/or procedure-related Adverse Events (AEs)
Measured: from attempted procedure to 12 months post-procedure
Incidence of device and/or procedure-related Serious Adverse Events (SAEs)
Measured: 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.
Measured: 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.
Measured: at procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start21 Jun 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by Lifetech Scientific (Shenzhen) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099015
- Sponsor's protocol ID
- LT-TS-22CE-04-01
- Status last verified
- Jun 2026
- First submitted
- 17 Oct 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study
- ClinicalTrials.gov ID
- NCT06099015
- Acronym / sponsor ID
- LT-TS-22CE-04-01
- Conditions
- Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension, Arteriovenous Fistula, Splenic Laceration
- Keywords
- Lifetech, Cera Vascular Plug
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cera Vascular Plug Subjects | – | Device: Cera™ Vascular Plug SystemPatients who need arterial or venous embolization in the peripheral vasculature. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who need arterial or venous embolization in the peripheral vasculature.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cera™ Vascular Plug SystemThe 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. | Device | Cera Vascular Plug Subjects |
Primary outcome
Technical success
Time frame: at procedure
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm and Endoleak, run by Lifetech Scientific (Shenzhen) Co., Ltd. at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Italy, Turkey (Türkiye), Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rae Gong ((86-755)-86026250-6957, gongrui@lifetechmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: at procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.