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

Not yet recruiting

• Conditions: Aneurysm; Portal Hypertension; Endoleak; Pulmonary Arteriovenous Malformation; Splenic Laceration; Arteriovenous Fistula
• Interventions: Device: Cera™ Vascular Plug System

• Registration Number: NCT06099015
• Lead Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-22
• Last Update Submitted: 2023-10-22
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-25
• Study Start: 2024-06
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cera Vascular Plug Subjects	Cera™ Vascular Plug System	Patients who need arterial or venous embolization in the peripheral vasculature.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 Serious Adverse Events (SAEs)	from attempted procedure to 12 months post-procedure
Incidence of device and/or procedure-related Adverse Events (AEs)	from attempted procedure to 12 months post-procedure
Time to occlusion	at procedure	Defined as the time from the device placement to complete occlusion of the target embolization sites.
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 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.

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, Italy