WeFlow-EndoSeal™ Aorta Vascular Plug System for the Treatment of Stanford Type B Aortic Dissection
2026年6月14日 更新者：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
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
256
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Huang Jin Jing
- 電話番号：13916287877
- メール：jingjing.huang@endonom.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100853
- 募集
- First Medical Center of The Chinese PLA General Hospital
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コンタクト：
- Guo Wei
- 電話番号：+86 13910758706
- メール：Pla301dml@vip.sina.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
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WeFlow-EndoSeal™ Aorta Vascular Plug System
Thoracic Endovascular Aortic Repair（TEVAR）
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アクティブコンパレータ：control group
The control group will receive conventional TEVAR treatment in accordance with guidelines and expert consensus.
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Thoracic Endovascular Aortic Repair（TEVAR）
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The 12-month Clinical Success Rate
時間枠：12 months postoperatively
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12 months postoperatively
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Incidence of freedom from major adverse events within 30 days postoperatively.
時間枠：30 days postoperatively
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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.
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30 days postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Immediate Technical Success Rate in the Test Group
時間枠：Intraoperative
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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.
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Intraoperative
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Thrombosis Status of the False Lumen in the Descending Thoracic Aorta
時間枠：30 days, 6 months, 12 months, and 24-60 months postoperatively
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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).
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30 days, 6 months, 12 months, and 24-60 months postoperatively
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Change in the Maximum Diameter of the Descending Thoracic Aorta
時間枠：30 days, 6 months, 12 months, and 24-60 months postoperatively
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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.
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30 days, 6 months, 12 months, and 24-60 months postoperatively
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Change in Volume in the Descending Thoracic Aorta
時間枠：30 days, 6 months, 12 months, and 24-60 months postoperatively
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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.
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30 days, 6 months, 12 months, and 24-60 months postoperatively
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Rate of Secondary Surgical Intervention
時間枠：30 days, 6 months, 12 months, and 24-60 months postoperatively
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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.
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30 days, 6 months, 12 months, and 24-60 months postoperatively
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Migration of the Aorta Vascular Plug
時間枠：6 months, 12 months, and 24-60 months postoperatively
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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.
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6 months, 12 months, and 24-60 months postoperatively
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All-cause mortality, aortic dissection-related mortality, incidence of serious adverse events, and incidence of device-related adverse events.
時間枠：30 days, 6 months, 12 months, and 24-60 months postoperatively.
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30 days, 6 months, 12 months, and 24-60 months postoperatively.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月1日
一次修了 (推定)
2032年3月1日
研究の完了 (推定)
2032年3月1日
試験登録日
最初に提出
2026年6月14日
QC基準を満たした最初の提出物
2026年6月14日
最初の投稿 (実際)
2026年6月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月14日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。