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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| control group | Active Comparator | The control group will receive conventional TEVAR treatment in accordance with guidelines and expert consensus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WeFlow-EndoSeal™ Aorta Vascular Plug System | Device | WeFlow-EndoSeal™ Aorta Vascular Plug System |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 12-month Clinical Success Rate | 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. | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Jin Jing | Contact | 13916287877 | jingjing.huang@endonom.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Medical Center of The Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2025 | Jun 14, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000094682 | Endovascular Aneurysm Repair |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Thoracic Endovascular Aortic Repair(TEVAR) | Procedure | Thoracic Endovascular Aortic Repair(TEVAR) |
|
| 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). |
| 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. | 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. | 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. | 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. | 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. | 30 days, 6 months, 12 months, and 24-60 months postoperatively. |
| D019917 | Blood Vessel Prosthesis Implantation |
| D058017 | Vascular Grafting |
| D019060 | Minimally Invasive Surgical Procedures |
| D019919 | Prosthesis Implantation |