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Clinical Trials in China / NCT06945809
Recruiting Not applicable

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

NCT06945809 · tracked via the Priya Life Science China tracker
Sponsor
Hangzhou Endonom Medtech Co., Ltd.
Phase
Not applicable
Started
2026-07-13
Last updated
2026-08-26

Condition(s) studied

Aortic DissectionDistal Entry Tear

Investigational drug(s) / intervention(s)

WeFlow-EndoPatch Aortic Endovascular Patch SystemConventional Treatment group

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.

Conventional Treatment group: Doctors prescribe conventional medicines and regular imaging tests.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing Beijing Municipality Recruiting

More Hangzhou Endonom Medtech Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06945809 on ClinicalTrials.gov ↗ ← All trials in China