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

Portal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06099015
• Other study ID #: LT-TS-22CE-04-01
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Lifetech Scientific (Shenzhen) Co., Ltd.
• Contact: Rae Gong
• Phone: (86-755)-86026250-6957
• Email: gongrui[@]lifetechmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Arteriovenous Fistula
• Arteriovenous Malformations
• Endoleak
• Fistula
• Hypertension, Portal
• Lacerations
• Portal Hypertension
• Pulmonary Arteriovenous Malformation

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lifetech Scientific (Shenzhen) Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Incidence of device and/or procedure-related Adverse Events (AEs)		from attempted procedure to 12 months post-procedure
Secondary	Incidence of device and/or procedure-related Serious Adverse Events (SAEs)		from attempted procedure to 12 months post-procedure
Secondary	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
Secondary	Time to occlusion	Defined as the time from the device placement to complete occlusion of the target embolization sites.	at procedure