WeFlow-EndoSeal Aorta Vascular Plug System added to TEVAR for Stanford Type B Aortic Dissection
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
Run by Hangzhou Endonom Medtech Co., Ltd. · NCT07658651 · Data updated 2026-11-12
This trial tests whether adding the WeFlow-EndoSeal vascular plug to TEVAR helps patients with Stanford type B dissection more than TEVAR alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 256 (estimated) |
| Sponsor | Hangzhou Endonom Medtech Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | March 1, 2032 |
| Study ends | March 1, 2032 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT07658651 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–80 with subacute or chronic Stanford Type B dissection scheduled for TEVAR and suitable vascular access.
✕Probably not a fit
Patients without favorable anatomy or those who do not tolerate the devices may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized controlled trial comparing two treatment approaches for subacute or chronic Stanford type B aortic dissection: TEVAR alone versus TEVAR plus the WeFlow-EndoSeal Aorta Vascular Plug System. Participants are adults aged 18 to 80 undergoing TEVAR and randomly assigned in a 1:1 ratio. The study aims to assess safety and efficacy of the combined approach, focusing on therapeutic outcomes without increasing adverse events. The trial collects imaging and clinical follow-up data to evaluate false lumen occlusion, aortic remodeling, and complication rates. Lead sponsor is Hangzhou Endonom Medtech Co., Ltd., with the first participating center at The Chinese PLA General Hospital in Beijing.
Why it matters
Potential benefit: If successful, patients may experience better aortic repair with potentially fewer complications compared to TEVAR alone.
How similar studies have gone: The efficacy of adjunct devices with TEVAR has shown promise in some studies, but results are context-dependent and this trial aims to provide direct comparative data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 to 80 years old. 2. Patients are diagnosed with subacute or chronic Stanford Type B aortic dissection and are scheduled to undergo TEVAR. 3. 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.. 4. 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. 5. 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. Exclusion Criteria: 1. Presence of persistent malperfusion of visceral arterial branches caused by dissection. 2. ■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■. 3. Infectious aortic disease, Takayasu's arteritis, Marfan syndrome (or other connective tissue diseases). 4. Acute systemic infection. 5. History of myocardial infarction, TIA, or stroke within the past 3 months. 6. NYHA Class IV cardiac dysfunction (see Appendix 1 of the protocol) or LVEF \< 30%. 7. Hematologic abnormalities, defined as: leukopenia (WBC \< 3×10⁹/L), anemia (Hb \< 90 g/L); coagulopathy, thrombocytopenia (PLT count \< 50×10⁹/L). 8. 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. 9. Severe hepatic insufficiency: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5× upper limit of normal; serum total bilirubin (STB) \> 2× upper limit of normal. 10. Hypersensitivity to contrast media, materials of the Aorta Vascular Plug, or the delivery system. 11. Female subjects who are pregnant or breastfeeding. 12. Concurrent participation in another clinical trial of drugs or devices. 13. Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumor). 14. 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: 1. Presence of other vascular lesions (e.g., coronary, renal, mesenteric arteries, etc.) requiring intervention, resulting in an impact on the postoperative medical regimen. 2. Proximal Type I endoleak or Type III endoleak. 3. Presence of a tear in the descending aorta above the upper margin of the celiac trunk ostium.
Where it's running
-
First Medical Center of The Chinese PLA General Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Huang Jin Jing
- Email: jingjing.huang@endonom.com
- Phone: 13916287877
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluation of Cratos™ Stent Graft for Treating Descending Aorta Lesions
This study is testing a new stent graft to see if it can safely help people with problems in their descending aorta, like tears or ulcers, and will follow them for a year to check how well it works.
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WeFlow-EndoPatch for Distal Aortic Tear Repair in Chronic Dissection
This study tests whether the WeFlow-EndoPatch Aortic Endovascular Patch can safely and effectively seal distal tears in chronic aortic dissection compared with standard treatment.
-
A study on a new stent graft system for aortic arch aneurysms
This study is testing a new stent graft system to see if it can safely and effectively treat aortic arch aneurysms in patients.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.