Aortic DissectionGallantNCT06945809

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

A study testing WeFlow-EndoPatch Aortic Endovascular Patch System and Conventional Treatment group in people with Aortic Dissection and Distal Entry Tear, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Aortic Dissection, Distal Entry Tear
What is being tested?: WeFlow-EndoPatch Aortic Endovascular Patch System and Conventional Treatment group
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 1 siteChina
Study dates: 13 Jul 2026to Oct 2032
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.);

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Guo contact

13910758706

Pla301dml@vip.sina.com

China1 site, 1 recruiting

Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Recruiting

Other trials in China

About this study

Official title: Guo&Amp;'s Distal Entry Tear Repair: a Multicenter, Prospective, Superiority, Randomized Controlled Trial of the Novel WeFlow-EndoPatch Aortic Endovascular Patch System

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.

Conditions: Aortic Dissection, Distal Entry Tear
Being tested: WeFlow-EndoPatch Aortic Endovascular Patch System, Conventional Treatment group
Keywords: Aortic Dissection, Distal tear, descending aorta
Medical subject headings: Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WeFlow-EndoPatch Aortic Endovascular Patch SystemDevice
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 groupOther
Doctors prescribe conventional medicines and regular imaging tests.

Study groups in NCT06945809
Study group	Role	What they receive
EndoPatch Group	Experimental	Subject in this group will receive treatment with the WeFlow-EndoPatch Aortic Endovascular Patch System. Receives: Device: WeFlow-EndoPatch Aortic Endovascular Patch System
Control Group	Other	Subject in this group will receive conventional treatment. Receives: Other: Conventional Treatment group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (8)

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.
Measured: Immediately after the surgery
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.
Measured: 30 days, 6 months, and 12 months
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.
Measured: 30 days, 6 months, and 12 months
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.
Measured: 30 days, 6 months, and 12 months
Device and/or Procedure Related Reinterventions
Measured: 30 days, 6 months, and 12 months
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.
Measured: Before discharge, 30 days after surgery
Patch Fall-off in EndoPatch Group
Measured: 30 days, 6 months, and 12 months
All-cause Mortality, Aortic Dissection-related Mortality, Serious Adverse Events, and Device-related Adverse Events
Measured: 30 days, 6 months, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 2026Oct 2032

First posted25 Apr 2025
Study start13 Jul 2026
Primary completionOct 2028 (estimated)
Study completionOct 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Aortic DissectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, multicenter, superiority, randomized controlled trial with 1:1 allocation to test group (aortic endovascular patch system) or control group (conservative medical management)
Masking: None (open label)
Enrolment: 216 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06945809
Sponsor's protocol ID: WQ11-2402
Acronym: Gallant
Status last verified: Aug 2026
First submitted: 18 Apr 2025
Last updated: 26 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Interested in taking part?

Wei Guo

13910758706

Pla301dml@vip.sina.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Aortic Dissection trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Guo&Amp;'s Distal Entry Tear Repair: a Multicenter, Prospective, Superiority, Randomized Controlled Trial of the Novel WeFlow-EndoPatch Aortic Endovascular Patch System
ClinicalTrials.gov ID: NCT06945809
Acronym / sponsor ID: Gallant / WQ11-2402
Conditions: Aortic Dissection, Distal Entry Tear
Keywords: Aortic Dissection, Distal tear, descending aorta
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 216 participants (estimated)
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
Study start: 13 Jul 2026 (actual)
Primary completion: Oct 2028 (estimated)
Study completion: Oct 2032 (estimated)
First posted: 25 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective, multicenter, superiority, randomized controlled trial with 1:1 allocation to test group (aortic endovascular patch system) or control group (conservative medical management)

Arm	Type	Receives
EndoPatch Group	Experimental	Device: WeFlow-EndoPatch Aortic Endovascular Patch SystemSubject in this group will receive treatment with the WeFlow-EndoPatch Aortic Endovascular Patch System.
Control Group	Other	Other: Conventional Treatment groupSubject in this group will receive conventional treatment.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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；

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WeFlow-EndoPatch Aortic Endovascular Patch SystemThe 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.	Device	EndoPatch Group
Conventional Treatment groupDoctors prescribe conventional medicines and regular imaging tests.	Other	Control Group

Primary outcome

Treatment Success Rate
Time frame: 12 months
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.

8 secondary outcomes

Immediate Technical Success in EndoPatch Group
Time frame: Immediately after the surgery
Entry Tears Closure Success in EndoPatch Group
Time frame: 30 days, 6 months, and 12 months
False Lumen Thrombosis of the Descending Thoracic Aorta
Time frame: 30 days, 6 months, and 12 months
True Lumen/False Lumen/Maximum Total Diameter of Descending Thoracic Aorta
Time frame: 30 days, 6 months, and 12 months
Device and/or Procedure Related Reinterventions
Time frame: 30 days, 6 months, and 12 months
No major adverse events within 30 days after surgery
Time frame: Before discharge, 30 days after surgery
Patch Fall-off in EndoPatch Group
Time frame: 30 days, 6 months, and 12 months
All-cause Mortality, Aortic Dissection-related Mortality, Serious Adverse Events, and Device-related Adverse Events
Time frame: 30 days, 6 months, and 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Results publication: PubMed 25173340Erbel 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.
Results publication: PubMed 22891838Hofferberth 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.
Results publication: PubMed 24918196Kolbel 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.
Results publication: PubMed 28438361Zhu 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.
Results publication: PubMed 30081168Wojciechowski 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.
Results publication: PubMed 26874601David 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.
Results publication: PubMed 32205112Nienaber 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.
Individual participant dataSharing planned: No

Related trials for Aortic Dissection

Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
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Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Wei Guo contact

13910758706

Pla301dml@vip.sina.com

Wei Guo principal investigator

Chinese PLA Gencral Hosptial

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Guo (13910758706, Pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Success Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06945809, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.