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

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

Study Overview

• Status: Recruiting
• Conditions: Aneurysm; Portal Hypertension; Arteriovenous Fistula; Endoleak; Pulmonary Arteriovenous Malformation; Splenic Laceration
• Intervention / Treatment: Device: Cera™ Vascular Plug System

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 Type: Observational
• Enrollment (Estimated): 132

Contacts and Locations

• Study Contact: Name: Rae Gong; Phone Number: (86-755)-86026250-6957; Email: gongrui@lifetechmed.com

Study Locations

• Germany
  • Bad Hersfeld, Germany
    • Recruiting
    • Klinikum Bad Hersfeld GmbH
    • Contact: Ahmed Mashhour
• Italy
  • Milan, Italy
    • Recruiting
    • Irccs Ospedale San Raffaele
    • Contact: Andrea Kahlberg
  • Milan, Italy
    • Recruiting
    • ASST Grande Ospedale Metropolitano Niguarda
    • Contact: Alberto Froio
  • Turin, Italy
    • Recruiting
    • A.O.U. Città della Salute e Della Scienza di Torino
    • Contact: Floriana Nardelli
  • Varese, Italy
    • Recruiting
    • Ospedale Di Circolo
    • Contact: Federico Fontana
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye)
    • Recruiting
    • Adana City Hospital
    • Contact: Ferid Cereb
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • Ankara University Hospital
    • Contact: Emre Celebioğlu
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • Bilkent City Hospital
    • Contact: Ibrahim Ece

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cera Vascular Plug Subjects; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically relevant recanalization	Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention.	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.	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	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.	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.	at procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 22, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Lifetech; Cera Vascular Plug
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Digestive System Diseases; Hemorrhage; Liver Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Postoperative Hemorrhage; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hypertension, Portal; Aneurysm; Arteriovenous Fistula; Endoleak; Pulmonary Arteriovenous Fistulas
• Other Study ID Numbers: LT-TS-22CE-04-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No