WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection

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

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

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection Type B
• Intervention / Treatment: Device: WeFlow-EndoSeal™ Aorta Vascular Plug System; Procedure: Thoracic Endovascular Aortic Repair（TEVAR）

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huang Jin Jing; Phone Number: 13916287877; Email: jingjing.huang@endonom.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100853
      • Recruiting
      • First Medical Center of The Chinese PLA General Hospital
      • Contact: Guo Wei; Phone Number: +86 13910758706; Email: Pla301dml@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; 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	Device: WeFlow-EndoSeal™ Aorta Vascular Plug System; WeFlow-EndoSeal™ Aorta Vascular Plug System; Procedure: Thoracic Endovascular Aortic Repair（TEVAR）; Thoracic Endovascular Aortic Repair（TEVAR）
Active Comparator: control group; The control group will receive conventional TEVAR treatment in accordance with guidelines and expert consensus.	Procedure: Thoracic Endovascular Aortic Repair（TEVAR）; Thoracic Endovascular Aortic Repair（TEVAR）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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.

Collaborators and Investigators

• Sponsor: Hangzhou Endonom Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 14, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 14, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Vascular Grafting; Prosthesis Implantation; Blood Vessel Prosthesis Implantation; Endovascular Aneurysm Repair
• Other Study ID Numbers: WQ202502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No