Aortic Dissection Type B
Conditions
Brief 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. 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
Interventions
DEVICEWeFlow-EndoSeal™ Aorta Vascular Plug System
WeFlow-EndoSeal™ Aorta Vascular Plug System
PROCEDUREThoracic Endovascular Aortic Repair（TEVAR）
Thoracic Endovascular Aortic Repair（TEVAR）
Sponsors
Hangzhou Endonom Medtech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 12-month Clinical Success Rate | 12 months postoperatively | — |
| Incidence of freedom from major adverse events within 30 days postoperatively. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Technical Success Rate in the Test Group | Intraoperative | 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. |
| Thrombosis Status of the False Lumen in the Descending Thoracic Aorta | 30 days, 6 months, 12 months, and 24-60 months postoperatively | 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). |
| Change in the Maximum Diameter of the Descending Thoracic Aorta | 30 days, 6 months, 12 months, and 24-60 months postoperatively | 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. |
| Change in Volume in the Descending Thoracic Aorta | 30 days, 6 months, 12 months, and 24-60 months postoperatively | 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. |
| Rate of Secondary Surgical Intervention | 30 days, 6 months, 12 months, and 24-60 months postoperatively | 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. |
| Migration of the Aorta Vascular Plug | 6 months, 12 months, and 24-60 months postoperatively | 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. |
| All-cause mortality, aortic dissection-related mortality, incidence of serious adverse events, and incidence of device-related adverse events. | 30 days, 6 months, 12 months, and 24-60 months postoperatively. | — |
Countries
China
Contacts
CONTACTHuang Jin Jing
Outcome results
None listed