Guo's False Lumen Embolization : The First in Man Study of WeFlow-EndoSeal Aorta Vascular Plug System

Hangzhou Endonom Medtech

Status

Enrolling

Conditions

Aortic Dissection Aneurysm

Treatments

Device: Aorta Vascular Plug System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06062524

Endoseal V1.0

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.