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

NCT ID: NCT06945809

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2032-10-31

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)

Detailed 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.

Conditions

Aortic Dissection; Distal Entry Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EndoPatch Group

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

Group Type: EXPERIMENTAL

WeFlow-EndoPatch Aortic Endovascular Patch System

Intervention Type: DEVICE

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.

Control Group

Subject in this group will receive conventional treatment.

Group Type: OTHER

Conventional Treatment group

Intervention Type: OTHER

Doctors prescribe conventional medicines and regular imaging tests.

Interventions

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.

Intervention Type: DEVICE

Conventional Treatment group

Doctors prescribe conventional medicines and regular imaging tests.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Endonom Medtech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Guo

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA Gencral Hosptial

Central Contacts

Wei Guo

Role: CONTACT

Pla301dml@vip.sina.com

13910758706

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

WQ11-2402

Identifier Type: -

Identifier Source: org_study_id