WeFlow-EndoPatch Aortic Endovascular Patch SystemConventional Treatment group
WeFlow-EndoPatch Aortic Endovascular Patch System: The WeFlow-EndoPatch Aortic Endovascular Patch System for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable.
A Multicenter, Randomized Controlled Study About the Safety and Efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for Chronic Aortic Dissection . (GALLANT Study)
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients aged 18 to 80 years old, no gender limitation;
* The patient was diagnosed with chronic aortic dissection after the repair of the main artery dissection, with distal tears required seal;
* The maximum diameter of the descending thoracic aorta is 3.5-5cm;
* The number of thoracic descending aorta tears is ≤2, and the maximum diameter of the tears is 2-30 mm;
* With appropriate artery approaches, endovascular treatment can be performed;
* 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:
* Rupture or threatened rupture of aortic dissection;
* Proximal type I internal leakage after aortic repair;
* New distal SINE;
* Abdominal aortic dissection aneurysm diameter ≥5 cm;
* The edge of the tear from the opening of celiac trunk is\<4 mm;
* The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.);
* 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, patchs, and delivery materials;
* Pregnant or breastfeeding;
* 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 outcome measure(s)
Treatment Success Rate — 12 months The success rate of aortic dissection treatment at 12 months is a composite index, including immediate technical success after surgery, freedom from death or aortic dissection rupture, positive aortic remodeling, and freedom from device and/or procedure related reinterventions.
Trial sites (1)
Facility
City
Region
Status
Chinese PLA General Hospital
Beijing
Beijing Municipality
Recruiting
More Hangzhou Endonom Medtech Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.