Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study) (NCT06945809) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)
204 participantsStarted 2025-10
Plain-language summary
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)
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 3.5-5cmï¼›
* 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 performedï¼›
* 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:…