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

Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06099015

Collaborator

(none)

132

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aneurysm Endoleak Pulmonary Arteriovenous Malformation Portal Hypertension Arteriovenous Fistula Splenic Laceration	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 Design

Study Type:

Observational

Anticipated Enrollment :

132 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study

Anticipated Study Start Date :

Jun 1, 2024

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Technical success [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.

Secondary Outcome Measures

Incidence of clinically relevant recanalization [at 3 months, 6 months, and 12 months post-procedure]
Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention.
Incidence of clinically relevant migration [at 3 months, 6 months, and 12 months post-procedure]
Clinically relevant migration is defined as migration of the study device from the target embolization site that requires a re-intervention.
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]
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 to occlusion [at procedure]
Defined as the time from the device placement to complete occlusion of the target embolization sites.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.