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

14 juni 2026 bijgewerkt door: Hangzhou Endonom Medtech Co., Ltd.

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

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

256

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Werving
        • First Medical Center of The Chinese PLA General Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Apparaat: WeFlow-EndoSeal™ Aorta Vascular Plug System
WeFlow-EndoSeal™ Aorta Vascular Plug System
Procedure: Thoracic Endovascular Aortic Repair（TEVAR）
Thoracic Endovascular Aortic Repair（TEVAR）
Actieve vergelijker: 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）

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The 12-month Clinical Success Rate
Tijdsspanne: 12 months postoperatively
12 months postoperatively
Incidence of freedom from major adverse events within 30 days postoperatively.
Tijdsspanne: 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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hangzhou Endonom Medtech Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 juni 2026

Primaire voltooiing (Geschat)

1 maart 2032

Studie voltooiing (Geschat)

1 maart 2032

Studieregistratiedata

Eerst ingediend

14 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 juni 2026

Eerst geplaatst (Werkelijk)

22 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

14 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • WQ202502

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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