Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)

Launched by HANGZHOU ENDONOM MEDTECH CO., LTD. · Apr 18, 2025

Keywords

ClinConnect Summary

The Gallant Study is a clinical trial that aims to evaluate the safety and effectiveness of a new device called the WeFlow-EndoPatch System, which is designed to treat patients with chronic aortic dissection. This condition involves tears in the aorta, the major artery that carries blood from the heart, specifically in the part of the aorta that runs down the chest. The trial is looking for participants aged between 18 and 80 who have been diagnosed with this condition after previous surgery for a main artery dissection. Eligible patients must have specific characteristics, such as a certain size of the aorta and a limited number of tears.

If you or a loved one are considering participation, you can expect to have a thorough evaluation to determine eligibility. The study will involve receiving treatment with the WeFlow-EndoPatch and following up with healthcare providers to monitor outcomes. It's important to note that certain health issues, like severe heart conditions or infections, may prevent someone from participating. This trial is not yet recruiting, but it represents an important step in exploring new treatment options for those affected by aortic dissection.

Gender

ALL

Eligibility criteria

• 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 \&lt; 30%;
• • Hematological abnormalities: leukopenia (WBC \&lt; 3×10\^9/L), anemia (Hb \&lt; 90 g/L); Coagulation dysfunction, thrombocytopenia (PLT count \&lt; 50×10\^9/L);
• • Renal insufficiency: serum creatinine \&gt; 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.