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New treatment option for Aortic Dissection Type B
Official title WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection
ClinicalTrials.gov ID: NCT07658651
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Patients have suitable access conditions evaluated by imaging, allowing the steerable catheter delivery systems to enter the false lumen via the...
- Patients are able to understand the purpose of the trial, participate in this study voluntarily, has signed the informed consent form personally or...
You likely can't join if
- 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%.
See the full eligibility criteria
- 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...
- 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%.
- 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 people 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.