Status:
NOT_YET_RECRUITING
Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)
Lead Sponsor:
Hangzhou Endonom Medtech Co., Ltd.
Conditions:
Aortic Dissection
Distal Entry Tear
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 Di...
Detailed Description
This study is a multicenter, prospective, superiority, randomized controlled trial about the safety and efficacy of WeFlow-EndoPatch Aortic Endovascular Patch System. It is expected to complete the im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2032
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06945809
Start Date
October 1 2025
End Date
October 1 2032
Last Update
April 30 2025
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