NCT06945809 Guo&Amp;'s Distal Entry Tear Repair With WeFlow-EndoPatch System (Gallant Study)
| NCT ID | NCT06945809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hangzhou Endonom Medtech Co., Ltd. |
| Condition | Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2026-07-13 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2026-07-13 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Dissection . (GALLANT Study)
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 \< 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.
Contact & Investigator
Wei Guo
PRINCIPAL INVESTIGATOR
Chinese PLA Gencral Hosptial
Frequently Asked Questions
Who can join the NCT06945809 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aortic Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06945809 currently recruiting?
Yes, NCT06945809 is actively recruiting participants. Contact the research team at Pla301dml@vip.sina.com for enrollment information.
Where is the NCT06945809 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06945809 clinical trial?
NCT06945809 is sponsored by Hangzhou Endonom Medtech Co., Ltd.. The principal investigator is Wei Guo at Chinese PLA Gencral Hosptial. The trial plans to enroll 216 participants.