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NCT06945809

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

Sponsor: Hangzhou Endonom Medtech Co., Ltd.

View on ClinicalTrials.gov

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)

Official title: Guo&Amp;'s Distal Entry Tear Repair: a Multicenter, Prospective, Superiority, Randomized Controlled Trial of the Novel WeFlow-EndoPatch Aortic Endovascular Patch System

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2025-10

Completion Date

2032-10

Last Updated

2025-04-30

Healthy Volunteers

Conditions

Aortic Dissection Distal Entry Tear

Interventions

DEVICE

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.

OTHER

Conventional Treatment group

Doctors prescribe conventional medicines and regular imaging tests.

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.