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

NCT07658651 | Recruiting DMC

• 1 other identifier: WQ202502
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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

Conditions

Aortic Dissection Type B

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Immediate Technical Success Rate in the Test Group

  Intraoperative

• Thrombosis Status of the False Lumen in the Descending Thoracic Aorta

  30 days, 6 months, 12 months, and 24-60 months postoperatively

• 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

  30 days, 6 months, 12 months, and 24-60 months postoperatively

• Rate of Secondary Surgical Intervention

  30 days, 6 months, 12 months, and 24-60 months postoperatively

Study Arms (2)

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

Device: WeFlow-EndoSeal™ Aorta Vascular Plug System; Procedure: Thoracic Endovascular Aortic Repair（TEVAR）

control group

ACTIVE COMPARATOR

The control group will receive conventional TEVAR treatment in accordance with guidelines and expert consensus.

Procedure: Thoracic Endovascular Aortic Repair（TEVAR）

Interventions

WeFlow-EndoSeal™ Aorta Vascular Plug System DEVICE

WeFlow-EndoSeal™ Aorta Vascular Plug System

test group

Thoracic Endovascular Aortic Repair（TEVAR） PROCEDURE

Thoracic Endovascular Aortic Repair（TEVAR）

control group; test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 accordance with the protocol requirements.

You may not qualify 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%.
• 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 subjects 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.
• After completion of the stent-graft procedure (including implantation of stents for the proximal and/or distal tears as necessary), DSA angiography revealed:

Sponsors & Collaborators

• Hangzhou Endonom Medtech Co., Ltd.: lead

Study Sites (1)

First Medical Center of The Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Interventions

Endovascular Aneurysm Repair

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Central Study Contacts

Huang Jin Jing

CONTACT

13916287877; jingjing.huang@endonom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2032
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)