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

NCT06099015 | Recruiting

• 1 other identifier: LT-TS-22CE-04-01
• Study Type: observational
• Target: 132
• Locations: 3 countries
• Sites: 9

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

Conditions

Arteriovenous Fistula; Splenic Laceration; Aneurysm; Endoleak; Pulmonary Arteriovenous Malformation; Portal Hypertension

Keywords

Lifetech; Cera Vascular Plug

Outcome Measures

Primary Outcomes (1)

• 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.

  at procedure

Secondary Outcomes (6)

• Incidence of clinically relevant recanalization

  at 3 months, 6 months, and 12 months post-procedure

• Incidence of clinically relevant migration

  at 3 months, 6 months, and 12 months post-procedure

• Incidence of device and/or procedure-related Adverse Events (AEs)

  from attempted procedure to 12 months post-procedure

• Incidence of device and/or procedure-related Serious Adverse Events (SAEs)

  from attempted procedure to 12 months post-procedure

• Incidence of device deficiencies

  from attempted procedure to 12 months post-procedure

Study Arms (1)

Cera Vascular Plug Subjects

Patients who need arterial or venous embolization in the peripheral vasculature.

Device: Cera™ Vascular Plug System

Interventions

Cera™ Vascular Plug System DEVICE

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.

Cera Vascular Plug Subjects

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who need arterial or venous embolization in the peripheral vasculature.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (9)

Klinikum Bad Hersfeld GmbH

Bad Hersfeld, Germany

NOT YET RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

A.O.U. Città della Salute e Della Scienza di Torino

Turin, Italy

RECRUITING

Ospedale di Circolo

Varese, Italy

RECRUITING

Adana City Hospital

Adana, Turkey (Türkiye)

RECRUITING

Ankara University Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Aneurysm; Endoleak; Pulmonary Arteriovenous Fistulas; Hypertension, Portal; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Liver Diseases; Digestive System Diseases; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Vascular Fistula; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Central Study Contacts

Rae Gong

CONTACT

(86-755)-86026250-6957; gongrui@lifetechmed.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 25, 2023
• Study Start: June 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4); DE (1); TU (4)