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

Hangzhou Endonom Medtech

Status: Not yet enrolling

Conditions: Distal Entry Tear; Aortic Dissection

Treatments: Other: Conventional Treatment group; Device: WeFlow-EndoPatch Aortic Endovascular Patch System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06945809

WQ11-2402

Details and patient eligibility

About

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)

Full 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 implantation of 204 patients in 15 centers within 24 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24th month, 36th month, 48th month and 60th month postoperatively.

Enrollment: 204 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

EndoPatch Group

Experimental group

Description:

Subject in this group will receive treatment with the WeFlow-EndoPatch Aortic Endovascular Patch System.

Treatment:

Device: WeFlow-EndoPatch Aortic Endovascular Patch System

Control Group

Other group

Description:

Subject in this group will receive conventional treatment.

Treatment:

Other: Conventional Treatment group