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

Official title

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

Overview

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

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

Primary outcome measures

• The 12-month Clinical Success Rate [Time frame: 12 months postoperatively]
• Incidence of freedom from major adverse events within 30 days postoperatively. [Time frame: 30 days postoperatively]

Secondary outcome measures (7)

• Immediate Technical Success Rate in the Test Group [Time frame: Intraoperative]
• Thrombosis Status of the False Lumen in the Descending Thoracic Aorta [Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively]
• Change in the Maximum Diameter of the Descending Thoracic Aorta [Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively]
• Change in Volume in the Descending Thoracic Aorta [Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively]
• Rate of Secondary Surgical Intervention [Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively]
• Migration of the Aorta Vascular Plug [Time frame: 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. [Time frame: 30 days, 6 months, 12 months, and 24-60 months postoperatively.]

Eligibility criteria

Inclusion 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 accordance with the protocol requirements.

Exclusion criteria

• 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.

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:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• First Medical Center of The Chinese PLA General Hospital — Beijing

Identifiers

NCT: NCT07658651 · WQ202502

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗