Status:
RECRUITING
Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Aortic Dissection Aneurysm
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
A prospective, single-center, first in man study to evaluate the safety and efficacy of WeFlow-EndoSeal Aorta Vascular Plug System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the dissecting...
Eligibility Criteria
Inclusion
- Patients aged 18 to 80 years old, no gender limitation;
- 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:
- Aortic dissection aneurysm diameter ≥ 5.5cm
- The diameter of descending thoracic aorta dissection increased rapidly ≥5 mm/ year
- 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
- Aortic rupture;
- 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.
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06062524
Start Date
October 24 2023
End Date
May 31 2026
Last Update
May 22 2024
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese PLA Gencral Hosptial
Beijing, Beijing Municipality, China
2
The People's Hospital of Gaozhou
Gaozhou, Guangdong, China
3
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China