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

NCT06945809 | Not Yet Recruiting DMC

• 1 other identifier: WQ11-2402
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Aortic Dissection; Distal Entry Tear

Keywords

Aortic Dissection; Distal tear; descending aorta

Outcome Measures

Primary Outcomes (1)

• Treatment Success Rate

  The success rate of aortic dissection treatment at 12 months is a composite index, including immediate technical success after surgery, freedom from death or aortic dissection rupture, positive aortic remodeling, and freedom from device and/or procedure related reinterventions.

  12 months

Secondary Outcomes (8)

• Immediate Technical Success in EndoPatch Group

  Immediately after the surgery

• Entry Tears Closure Success in EndoPatch Group

  30 days, 6 months, and 12 months

• False Lumen Thrombosis of the Descending Thoracic Aorta

  30 days, 6 months, and 12 months

• True Lumen/False Lumen/Maximum Total Diameter of Descending Thoracic Aorta

  30 days, 6 months, and 12 months

• Device and/or Procedure Related Reinterventions

  30 days, 6 months, and 12 months

Study Arms (2)

EndoPatch Group

EXPERIMENTAL

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

Device: WeFlow-EndoPatch Aortic Endovascular Patch System

Control Group

OTHER

Subject in this group will receive conventional treatment.

Other: Conventional Treatment group

Interventions

WeFlow-EndoPatch Aortic Endovascular Patch System 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.

EndoPatch Group

Conventional Treatment group OTHER

Doctors prescribe conventional medicines and regular imaging tests.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Related Publications (7)

• Erbel R, Aboyans V, Boileau C, Bossone E, Bartolomeo RD, Eggebrecht H, Evangelista A, Falk V, Frank H, Gaemperli O, Grabenwoger M, Haverich A, Iung B, Manolis AJ, Meijboom F, Nienaber CA, Roffi M, Rousseau H, Sechtem U, Sirnes PA, Allmen RS, Vrints CJ; ESC Committee for Practice Guidelines. 2014 ESC Guidelines on the diagnosis and treatment of aortic diseases: Document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The Task Force for the Diagnosis and Treatment of Aortic Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2014 Nov 1;35(41):2873-926. doi: 10.1093/eurheartj/ehu281. Epub 2014 Aug 29. No abstract available.

  PMID: 25173340 RESULT

• Hofferberth SC, Nixon IK, Mossop PJ. Aortic false lumen thrombosis induction by embolotherapy (AFTER) following endovascular repair of aortic dissection. J Endovasc Ther. 2012 Aug;19(4):538-45. doi: 10.1583/JEVT-12-3844R.1.

  PMID: 22891838 RESULT

• Kolbel T, Tsilimparis N, Wipper S, Larena-Avellaneda A, Diener H, Carpenter SW, Debus ES. TEVAR for chronic aortic dissection - is covering the primary entry tear enough? J Cardiovasc Surg (Torino). 2014 Aug;55(4):519-27. Epub 2014 Jun 11.

  PMID: 24918196 RESULT

• Zhu C, Huang B, Zhao J, Ma Y, Yuan D, Yang Y, Xiong F, Wang T. Influence of distal entry tears in acute type B aortic dissection after thoracic endovascular aortic repair. J Vasc Surg. 2017 Aug;66(2):375-385. doi: 10.1016/j.jvs.2016.12.142. Epub 2017 Apr 21.

  PMID: 28438361 RESULT

• Wojciechowski J, Znaniecki L, Kaszubowski M, Rogowski J. Late Aortic Remodeling after Endovascular Repair of Complicated Type B Aortic Dissection-TEVAR Protects Only the Covered Segment of Thoracic Aorta. Ann Vasc Surg. 2019 Feb;55:148-156. doi: 10.1016/j.avsg.2018.05.057. Epub 2018 Aug 4.

  PMID: 30081168 RESULT

• David TE. Adventitial inversion in the distal anastomosis in surgical treatment of acute DeBakey type I aortic dissection. J Thorac Cardiovasc Surg. 2016 May;151(5):1346-7. doi: 10.1016/j.jtcvs.2016.01.028. Epub 2016 Jan 22. No abstract available.

  PMID: 26874601 RESULT

• Nienaber CA, Yuan X, Aboukoura M, Blanke P, Jakob R, Janosi RA, Lovato L, Riambau V, Trebacz J, Trimarchi S, Zipfel B, van den Berg JC; ASSIST study group. Improved Remodeling With TEVAR and Distal Bare-Metal Stent in Acute Complicated Type B Dissection. Ann Thorac Surg. 2020 Nov;110(5):1572-1579. doi: 10.1016/j.athoracsur.2020.02.029. Epub 2020 Mar 20.

  PMID: 32205112 RESULT

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Wei Guo

  Chinese PLA Gencral Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Guo

CONTACT

13910758706; Pla301dml@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2032
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share