New plug could boost aortic repair success
NCT ID NCT07658651
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a special plug (WeFlow-EndoSeal™) to standard stent-graft repair improves outcomes for people with a tear in the aorta's inner layer (type B aortic dissection). About 256 adults with subacute or chronic dissection will be randomly assigned to get the plug plus standard repair or standard repair alone. The main goal is to see if the plug increases the chance of successful treatment at 12 months without raising the risk of serious events like stroke or kidney failure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- WeFlow-EndoSeal™ Aorta Vascular Plug System
- What this could lead to
- If successful, this plug could make standard aortic repair more effective, reducing complications and improving long-term survival for people with aortic dissection.
- What could go wrong
- This is an early-stage device trial with 256 participants, so results may not apply broadly. Risks include procedural complications like bleeding, stroke, or device failure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 256 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2026
- Expected to finish
-
Mar 2032
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Aortic dissection type B are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
First Medical Center of The Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100853, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.