Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
NCT ID: NCT06062524
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-10-24
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WeFlow-EndoSeal Aorta Vascular Plug System
WeFlow-EndoSeal Aorta Vascular Plug System
Aorta Vascular Plug System
The Aorta Vascular Plug System for false lumen is composed of a vascular plug system and an adjustable bend conveyor. The plug system is composed of a patch and a conveying steel cable. The plug is pre-installed on the conveying steel cable.
Interventions
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Aorta Vascular Plug System
The Aorta Vascular Plug System for false lumen is composed of a vascular plug system and an adjustable bend conveyor. The plug system is composed of a patch and a conveying steel cable. The plug is pre-installed on the conveying steel cable.
Eligibility Criteria
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Inclusion Criteria
* The patient was diagnosed with a dissecting aneurysm of the descending thoracic aorta after the repair of the main artery dissection, and the treatment indications were one of the following:
1. Aortic dissection aneurysm diameter ≥ 5.5cm
2. The diameter of descending thoracic aorta dissection increased rapidly ≥5 mm/ year
3. Symptoms associated with dissection progression, such as chest and back pain
* The diameter of false lumen approximately 1 cm superiorly to the celiac trunk ≤40 mm
* Appropriate anatomical conditions were assessed by imaging to allow the adjustable bend conveyor to enter the pseudolumen through tears of the iliac artery, subrenal aorta, or renal artery levels.
* Those who can understand the purpose of the trial, voluntarily participate in the study, sign the informed consent form by themselves or their legal representative, and are willing to complete the follow-up according to the protocol requirements.
Exclusion Criteria
* Continuous malperfusion of internal artery branches caused by dissection;
* Had previously received false lumen embolization;
* Proximal type I endoleak after aortic repair;
* Abdominal aortic dissection aneurysm diameter \> 5 cm
* Infectious aortic disease, arteritis, Marfan syndrome (or other connective tissue diseases);
* Acute systemic infection;
* History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
* Cardiac function Grade IV (NYHA rating) or LVEF \< 30%;
* Hematological abnormalities: leukopenia (WBC \< 3×10\^9/L), anemia (Hb \< 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count \< 50×10\^9/L);
* Renal insufficiency: serum creatinine \> 150 umol/L (or 3.0 mg/dL) and/or advanced kidney disease requiring renal dialysis, as determined by the investigator after thorough analysis;
* Severe liver insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds the normal upper limit by 5 times; Serum total bilirubin (STB) exceeded the normal upper limit by 2 times;
* Allergic to contrast agents, anesthetics, plugs, and delivery materials;
* Pregnant, breastfeeding or cannot contraception during the trial period;
* Participated in clinical trials of other drugs or devices during the same period;
* Life expectancy is less than 12 months (such as advanced malignant tumors);
* Investigator judged that not suitable for interventional treatment.
18 Years
80 Years
ALL
No
Sponsors
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Hangzhou Endonom Medtech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chinese PLA Gencral Hosptial
Beijing, Beijing Municipality, China
The People's Hospital of Gaozhou
Gaozhou, Guangdong, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yu Cao, professor
Role: primary
Weiguo Fu, professor
Role: primary
Other Identifiers
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Endoseal V1.0
Identifier Type: -
Identifier Source: org_study_id
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