Clinical trial NCT06062524: Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
Official title: Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Dissection Aneurysm
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 aneurysm of descending thoracic aorta after aortic dissection repair.


Eligibility criteria: Inclusion Criteria:

* 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:

  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:

* 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.

Primary outcomes:
measure: No major adverse events within 30 days after operation.
timeFrame: 30 days after operation
measure: All-cause mortality
timeFrame: 30 days, 6 months, and 12 months after operation
measure: Aortic dissection-related mortality,
timeFrame: 30 days, 6 months, and 12 months after operation
measure: Serious adverse events.
timeFrame: 30 days, 6 months, and 12 months after operation
measure: False lumen thrombosis of the descending thoracic aorta
timeFrame: 1 month, 6 months, and 12 months after operation
measure: Aortic dissection progression under control
timeFrame: 1 month, 6 months, and 12 months after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA Gencral Hosptial
state: Beijing
city: Gaozhou
country: China
facility: The People's Hospital of Gaozhou
state: Guangdong
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References: