Aortic Dissection Type BNCT07658651
WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection
A study testing WeFlow-EndoSeal™ Aorta Vascular Plug System and Thoracic Endovascular Aortic Repair（TEVAR） in people with Aortic Dissection Type B, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site in China.
Trial summary
The goal of this prospective, multicenter, randomized controlled clinical trial is to evaluate the safety and efficacy of the WeFlow-EndoSeal™ vAorta Vascular Plug System combined with thoracic endovascular aortic repair (TEVAR) in patients diagnosed with Stanford type B aortic dissection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Dissection Type B
- What is being tested?
- WeFlow-EndoSeal™ Aorta Vascular Plug System and Thoracic Endovascular Aortic Repair（TEVAR）
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Mar 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.
- Patients are diagnosed with subacute or chronic Stanford Type B aortic dissection and are scheduled to undergo TEVAR.
- Upon imaging evaluation, The the maximum diameter of the false lumen landing zone where the vascular plug is intended to be deployed shall be in the descending thoracic aorta is ≤ ■■ mm..
- Patients have suitable access conditions evaluated by imaging, allowing the steerable catheter delivery systems to enter the false lumen via the iliac artery, infrarenal aorta, or at the level of the renal artery tear.
- Patients are able to understand the purpose of the trial, participate in this study voluntarily, has signed the informed consent form personally or via their legal representative, and is willing to complete follow-up in accordance with the protocol requirements.
Who cannot join
- Presence of persistent malperfusion of visceral arterial branches caused by dissection.
- ■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■.
- Infectious aortic disease, Takayasu's arteritis, Marfan syndrome (or other connective tissue diseases).
- Acute systemic infection.
- History of myocardial infarction, TIA, or stroke within the past 3 months.
- NYHA Class IV cardiac dysfunction (see Appendix 1 of the protocol) or LVEF < 30%.
Show all 19Show fewer
- Hematologic abnormalities, defined as: leukopenia (WBC < 3×10⁹/L), anemia (Hb < 90 g/L); coagulopathy, thrombocytopenia (PLT count < 50×10⁹/L).
- Renal insufficiency with serum creatinine > 221 μmol/L (or 2.5 mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by the investigator after comprehensive assessment.
- Severe hepatic insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5× upper limit of normal; serum total bilirubin (STB) > 2× upper limit of normal.
- Hypersensitivity to contrast media, materials of the Aorta Vascular Plug, or the delivery system.
- Female subjects who are pregnant or breastfeeding.
- Concurrent participation in another clinical trial of drugs or devices.
- Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumor).
- Any other medical conditions or abnormalities that, in the investigator's opinion, render the subject ineligible for this study.
- Intraoperative Angiography Exclusion Criteria
- After completion of the stent-graft procedure (including implantation of stents for the proximal and/or distal tears as necessary), DSA angiography revealed:
- Presence of other vascular lesions (e.g., coronary, renal, mesenteric arteries, etc.) requiring intervention, resulting in an impact on the postoperative medical regimen.
- Proximal Type I endoleak or Type III endoleak.
- Presence of a tear in the descending aorta above the upper margin of the celiac trunk ostium.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Medical Center of The Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Guo Wei, +86 13910758706, Pla301dml@vip.sina.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Safety and Efficacy of the WeFlow-EndoSeal™ Aorta Vascular Plug System Combined With TEVAR for the Treatment of Stanford Type B Aortic Dissection
The goal of this prospective, multicenter, randomized controlled clinical trial is to evaluate the safety and efficacy of the WeFlow-EndoSeal™ vAorta Vascular Plug System combined with thoracic endovascular aortic repair (TEVAR) in patients diagnosed with Stanford type B aortic dissection. The main questions it aims to answer are:
Does WeFlow-EndoSeal™ combined with TEVAR provide superior therapeutic efficacy versus standard TEVAR alone for Stanford type B aortic dissection? Does the combined intervention maintain a comparable safety profile relative to standard TEVAR alone? Researchers will compare the test arm (WeFlow-EndoSeal™ Aorta Vascular Plug System plus TEVAR) with the control arm (standard TEVAR alone), with subjects randomized at a 1:1 ratio, to see if the add-on device enhances treatment outcomes without elevating safety risks.
Read more
Participants will:
Be randomly assigned to either the test arm or the control arm with equal probability, free from subjective influence of investigators or participants Undergo the corresponding standardized endovascular procedure per their group allocation Complete protocol-specified clinical follow-ups and imaging assessments for efficacy and safety evaluation
- Conditions
- Aortic Dissection Type B
- Being tested
- WeFlow-EndoSeal™ Aorta Vascular Plug System, Thoracic Endovascular Aortic Repair（TEVAR）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WeFlow-EndoSeal™ Aorta Vascular Plug SystemDevice
WeFlow-EndoSeal™ Aorta Vascular Plug System
Thoracic Endovascular Aortic Repair（TEVAR）Procedure or surgery
Thoracic Endovascular Aortic Repair（TEVAR）
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | The test group will be treated with the WeFlow-EndoSeal™ Aorta Vascular Plug System developed and produced by Hangzhou Endonom Medtech Co., Ltd. combined with TEVAR for patients with Stanford Type B aortic dissection Receives: Device: WeFlow-EndoSeal™ Aorta Vascular Plug System; Procedure: Thoracic Endovascular Aortic Repair（TEVAR） |
| control group | Active comparator | The control group will receive conventional TEVAR treatment in accordance with guidelines and expert consensus. Receives: Procedure: Thoracic Endovascular Aortic Repair（TEVAR） |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 12-month Clinical Success Rate
Measured: 12 months postoperatively
Incidence of freedom from major adverse events within 30 days postoperatively.
Freedom from all-cause death, aortic rupture, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe lower extremity ischemia or necrosis, and paraplegia within 30 days postoperatively.
Measured: 30 days postoperatively
Secondary outcomes (7)
Immediate Technical Success Rate in the Test Group
Immediate technical success is defined as successful delivery of the Aorta Vascular Plug to the intended position, accurate positioning and successful deployment, with the delivery sheath safely withdrawn outside the body, and no conversion to open surgery.
Measured: Intraoperative
Thrombosis Status of the False Lumen in the Descending Thoracic Aorta
Compare CTA results obtained preoperatively and at 30 days, 6 months, 12 months, and 24-60 months postoperatively to assess the thrombosis status of the false lumen in the descending thoracic aorta (no thrombosis / partial thrombosis / complete thrombosis).
Measured: 30 days, 6 months, 12 months, and 24-60 months postoperatively
Change in the Maximum Diameter of the Descending Thoracic Aorta
Compare the CTA results obtained preoperatively and at 30 days, 6 months, 12 months, and 24-60 months postoperatively to assess the change in the maximum diameter of the descending thoracic aorta.
Measured: 30 days, 6 months, 12 months, and 24-60 months postoperatively
Change in Volume in the Descending Thoracic Aorta
Compare CTA results obtained preoperatively and at 30 days, 6 months, 12 months, and 24-60 months postoperatively to assess the change in true lumen, false lumen and total volume above the celiac trunk in the descending thoracic aorta.
Measured: 30 days, 6 months, 12 months, and 24-60 months postoperatively
Rate of Secondary Surgical Intervention
Secondary surgical intervention refers to open or endovascular reinterventions performed on subjects due to procedure-related and device-related complications or adverse events, including but not limited to aortic rupture, migration of the Aorta Vascular Plug, infection, etc. Secondary surgical intervention does not include scheduled elective procedures or non-aortic surgeries.
Measured: 30 days, 6 months, 12 months, and 24-60 months postoperatively
Migration of the Aorta Vascular Plug
Device migration is defined as displacement of the Aorta Vascular Plug by more than 10 mm at 6 months, 12 months, and 24-60 months postoperatively compared with that at 30 days postoperatively.
Measured: 6 months, 12 months, and 24-60 months postoperatively
All-cause mortality, aortic dissection-related mortality, incidence of serious adverse events, and incidence of device-related adverse events.
Measured: 30 days, 6 months, 12 months, and 24-60 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jun 2026
- Primary completion1 Mar 2032 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Dissection Type BStudies 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
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658651
- Sponsor's protocol ID
- WQ202502
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Safety and Efficacy of the WeFlow-EndoSeal™ Aorta Vascular Plug System Combined With TEVAR for the Treatment of Stanford Type B Aortic Dissection
- ClinicalTrials.gov ID
- NCT07658651
- Acronym / sponsor ID
- WQ202502
- Conditions
- Aortic Dissection Type B
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Hangzhou Endonom Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Mar 2032 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 22 Jun 2026 (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.
The goal of this prospective, multicenter, randomized controlled clinical trial is to evaluate the safety and efficacy of the WeFlow-EndoSeal™ vAorta Vascular Plug System combined with thoracic endovascular aortic repair (TEVAR) in patients diagnosed with Stanford type B aortic dissection. The main questions it aims to answer are:
Does WeFlow-EndoSeal™ combined with TEVAR provide superior therapeutic efficacy versus standard TEVAR alone for Stanford type B aortic dissection? Does the combined intervention maintain a comparable safety profile relative to standard TEVAR alone? Researchers will compare the test arm (WeFlow-EndoSeal™ Aorta Vascular Plug System plus TEVAR) with the control arm (standard TEVAR alone), with subjects randomized at a 1:1 ratio, to see if the add-on device enhances treatment outcomes without elevating safety risks.
Participants will:
Be randomly assigned to either the test arm or the control arm with equal probability, free from subjective influence of investigators or participants Undergo the corresponding standardized endovascular procedure per their group allocation Complete protocol-specified clinical follow-ups and imaging assessments for efficacy and safety evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Device: WeFlow-EndoSeal™ Aorta Vascular Plug System, Procedure: Thoracic Endovascular Aortic Repair（TEVAR）The test group will be treated with the WeFlow-EndoSeal™ Aorta Vascular Plug System developed and produced by Hangzhou Endonom Medtech Co., Ltd. combined with TEVAR for patients with Stanford Type B aortic dissection |
| control group | Active comparator | Procedure: Thoracic Endovascular Aortic Repair（TEVAR）The control group will receive conventional TEVAR treatment in accordance with guidelines and expert consensus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 80 years old.
- Patients are diagnosed with subacute or chronic Stanford Type B aortic dissection and are scheduled to undergo TEVAR.
- Upon imaging evaluation, The the maximum diameter of the false lumen landing zone where the vascular plug is intended to be deployed shall be in the descending thoracic aorta is ≤ ■■ mm..
- Patients have suitable access conditions evaluated by imaging, allowing the steerable catheter delivery systems to enter the false lumen via the iliac artery, infrarenal aorta, or at the level of the renal artery tear.
- Patients are able to understand the purpose of the trial, participate in this study voluntarily, has signed the informed consent form personally or via their legal representative, and is willing to complete follow-up in accordance with the protocol requirements.
Key exclusion criteria (19 listed)
- Presence of persistent malperfusion of visceral arterial branches caused by dissection.
- ■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■.
- Infectious aortic disease, Takayasu's arteritis, Marfan syndrome (or other connective tissue diseases).
- Acute systemic infection.
- History of myocardial infarction, TIA, or stroke within the past 3 months.
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-EndoSeal™ Aorta Vascular Plug SystemWeFlow-EndoSeal™ Aorta Vascular Plug System | Device | test group |
| Thoracic Endovascular Aortic Repair（TEVAR）Thoracic Endovascular Aortic Repair（TEVAR） | Procedure or surgery | control group, test group |
Primary outcome
The 12-month Clinical Success Rate
Time frame: 12 months postoperatively
Incidence of freedom from major adverse events within 30 days postoperatively.
Time frame: 30 days postoperatively
Freedom from all-cause death, aortic rupture, myocardial infarction, renal failure, respiratory failure, ischemic stroke, intestinal necrosis, severe lower extremity ischemia or necrosis, and paraplegia within 30 days postoperatively.
7 secondary outcomes
Immediate Technical Success Rate in the Test Group
Time frame: Intraoperative
Thrombosis Status of the False Lumen in the Descending Thoracic Aorta
Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively
Change in the Maximum Diameter of the Descending Thoracic Aorta
Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively
Change in Volume in the Descending Thoracic Aorta
Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively
Rate of Secondary Surgical Intervention
Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively
Migration of the Aorta Vascular Plug
Time frame: 6 months, 12 months, and 24-60 months postoperatively
All-cause mortality, aortic dissection-related mortality, incidence of serious adverse events, and incidence of device-related adverse events.
Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively.
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 22 Jun 2026.
- Individual participant dataSharing planned: Yes
Related trials for Aortic Dissection Type B
Recruiting
IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
Type B Aortic Dissection
Recruiting
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
Type B Aortic Dissection
Not yet recruitingObservational study
Type B Aortic Dissection Quality Control Platform
Endovascular Surgery, Medical Quality
Enrolling by invitationObservational study
Outcomes of Aortic Dissection Repair
Type A Aortic Dissection, Ascending Aortic Dissection
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Attenuation of Inflammatory Response and Blood Pressure in Type B Aortic Dissection
Type B Aortic Dissection
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WeFlow-EndoSeal™ Aorta Vascular Plug System and Thoracic Endovascular Aortic Repair（TEVAR） in people with Aortic Dissection Type B, run by Hangzhou Endonom Medtech Co., Ltd. at 1 site in China.
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 5 inclusion and 19 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 22 Jun 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 Huang Jin Jing (13916287877, jingjing.huang@endonom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 12-month Clinical Success Rate (time frame: 12 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.