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The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cera Vascular Plug Subjects | Patients who need arterial or venous embolization in the peripheral vasculature. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who need arterial or venous embolization in the peripheral vasculature.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rae Gong | Contact | (86-755)-86026250-6957 | gongrui@lifetechmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Bad Hersfeld GmbH | Recruiting | Bad Hersfeld | Germany |
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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 |
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | Italy |
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| IRCCS Ospedale San Raffaele | Recruiting | Milan | Italy |
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| A.O.U. Città della Salute e Della Scienza di Torino | Recruiting | Turin | Italy |
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| Ospedale di Circolo | Recruiting | Varese | Italy |
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| Adana City Hospital | Recruiting | Adana | Turkey (Türkiye) |
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| Ankara University Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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| Bilkent City Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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| Bilkent City Hospital | Recruiting | Ankara | Turkey (Türkiye) |
|
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D057867 | Endoleak |
| C562404 | Pulmonary Arteriovenous Fistulas |
| D006975 | Hypertension, Portal |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D019106 | Postoperative Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D016157 | Vascular Fistula |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
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