Clinical trial NCT06099015: Cera™ Vascular Plug System Post-Market Clinical Follow-Up
Official title: Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysm
Endoleak
Pulmonary Arteriovenous Malformation
Portal Hypertension
Arteriovenous Fistula
Splenic Laceration
Keywords: Lifetech
Cera Vascular Plug
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who need arterial or venous embolization in the peripheral vasculature.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical success
timeFrame: at procedure
Secondary outcomes:
measure: Incidence of clinically relevant recanalization
timeFrame: at 3 months, 6 months, and 12 months post-procedure
measure: Incidence of clinically relevant migration
timeFrame: at 3 months, 6 months, and 12 months post-procedure
measure: Incidence of device and/or procedure-related Adverse Events (AEs)
timeFrame: from attempted procedure to 12 months post-procedure
measure: Incidence of device and/or procedure-related Serious Adverse Events (SAEs)
timeFrame: from attempted procedure to 12 months post-procedure
measure: Incidence of device deficiencies
timeFrame: from attempted procedure to 12 months post-procedure
measure: Time to occlusion
timeFrame: at procedure
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References: