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
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%.
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- 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