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RecruitingNCT06945809GallantUpdated Aug 26, 2026

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

An interventional study of WeFlow-EndoPatch Aortic Endovascular Patch System and Conventional Treatment group in Aortic Dissection and Distal Entry Tear, sponsored by Hangzhou Endonom Medtech Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Hangzhou Endonom Medtech Co., Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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)

Read the 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.

02

Conditions studied

  • Aortic Dissection
  • Distal Entry Tear

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Keywords

  • Aortic Dissection
  • Distal tear
  • descending aorta
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    EndoPatch Group

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

    Device: WeFlow-EndoPatch Aortic Endovascular Patch System

  • Other
    Control Group

    Subject in this group will receive conventional treatment.

    Other: Conventional Treatment group

Interventions

  • DeviceWeFlow-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.

  • OtherConventional Treatment group

    Doctors prescribe conventional medicines and regular imaging tests.

05

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. Immediate Technical Success in EndoPatch Group

    Immediate technical success is defined as successful delivery of the endopatch conveyors to their predetermined positions, accurate positioning and successful deployment of the patch, safe removal of the delivery device outside the body, and no conversion to thoracotomy.

    Time frame: Immediately after the surgery

  2. Entry Tears Closure Success in EndoPatch Group

    Entry tears closure success is defined as absence of TL or FL backflow through the tears on CTA.

    Time frame: 30 days, 6 months, and 12 months

  3. False Lumen Thrombosis of the Descending Thoracic Aorta

    False lumen thrombosis of the descending thoracic aorta (no thrombosis, partial thrombosis, complete thrombosis) observed by postoperative CTA review.

    Time frame: 30 days, 6 months, and 12 months

  4. True Lumen/False Lumen/Maximum Total Diameter of Descending Thoracic Aorta

    True lumen diameter, false lumen diameter and maximum total diameter of the descending thoracic aorta observed by postoperative CTA review.

    Time frame: 30 days, 6 months, and 12 months

  5. Device and/or Procedure Related Reinterventions

    Time frame: 30 days, 6 months, and 12 months

  6. No major adverse events within 30 days after surgery

    Major adverse events within 30 days after surgery refer to all-cause death, aortic dissection rupture, myocardial infarction, ischemic stroke, respiratory failure, renal failure, intestinal necrosis, paraplegia, and amputation.

    Time frame: Before discharge, 30 days after surgery

  7. Patch Fall-off in EndoPatch Group

    Time frame: 30 days, 6 months, and 12 months

  8. All-cause Mortality, Aortic Dissection-related Mortality, Serious Adverse Events, and Device-related Adverse Events

    Time frame: 30 days, 6 months, and 12 months

06

Study locations

1 of 1 sites recruiting
  • Chinese PLA General Hospital
    Beijing, Beijing Municipality 100853, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 25173340 ↗
  • 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. PubMed 22891838 ↗
  • 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. PubMed 24918196 ↗
  • 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. PubMed 28438361 ↗
  • 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. PubMed 30081168 ↗
  • 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. PubMed 26874601 ↗
  • 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. PubMed 32205112 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 5, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06945809
Lead sponsor
Hangzhou Endonom Medtech Co., Ltd.
Responsible party
Sponsor
First posted
Apr 25, 2025
Start date
Jul 13, 2026
Primary completion
Oct 2028 (estimated)
Completion
Oct 2032 (estimated)
Last update
Aug 26, 2026

Study contacts

Wei Guo
Contact
Pla301dml@vip.sina.com
13910758706
Wei Guo
principal investigator · Chinese PLA Gencral Hosptial

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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