Safety and Effectiveness Assessment of AneuFix Injectable Polymer Sac Filling to Assure Long-term Durability of EVAR. (SEAL-EVAR)
SEAL-EVAR: Safety and Effectiveness Assessment of AneuFix Injectable Polymer Sac Filling to Assure Long-term Durability of EVAR. A Randomized Controlled Multicenter Trial.
The goal of this clinical trial is to evaluate the safety and effectiveness of adding AneuFix Injectable Polymer sac filling to standard endovascular aneurysm repair (EVAR) in patients with an infrarenal abdominal aortic aneurysm (AAA) who are at high risk of developing a Type II endoleak after EVAR. The study will include adult men and women who are candidates for elective EVAR and meet predefined imaging criteria indicating a high risk of post-procedural Type II endoleak.
The main questions it aims to answer are:
- Does the addition of AneuFix Injectable Polymer to standard EVAR reduce the occurrence of Type II endoleaks, prevent aneurysm sac growth, and reduce the need for AAA-related reinterventions within 12 months after treatment?
- Is treatment with AneuFix Injectable Polymer safe, as measured by the rate of major adverse events within 30 days after the procedure?
Researchers will compare EVAR plus AneuFix Injectable Polymer sac filling with standard EVAR alone to determine whether sac filling improves aneurysm-related outcomes and reduces complications associated with persistent blood flow into the aneurysm sac following EVAR.
Participants will:
- Undergo screening assessments, including review of medical history, imaging studies, and eligibility criteria.
- Be randomly assigned in a 2:1 ratio to receive either:
- Standard EVAR with AneuFix Injectable Polymer sac filling, or
- Standard EVAR alone.
- Attend follow-up visits at approximately 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years after treatment.
- Undergo imaging assessments, including CT angiography and ultrasound or magnetic resonance angiography, to evaluate the presence of endoleaks, aneurysm sac size, and other aneurysm-related outcomes.
- Be monitored for adverse events, reinterventions, aneurysm-related complications, and survival throughout the 5-year follow-up period.
- Complete quality-of-life questionnaires at selected study visits.
This multicenter, randomized, controlled study plans to enroll approximately 150 participants at sites across Europe and follow them for up to 5 years after treatment.
調査の概要
状態
詳細な説明
Abdominal aortic aneurysm (AAA) is a progressive disease that can lead to aneurysm rupture if left untreated. Endovascular aneurysm repair (EVAR) has become a widely used treatment option for infrarenal AAA because it is less invasive than open surgical repair. However, long-term durability of EVAR can be affected by complications, particularly endoleaks that allow persistent blood flow within the aneurysm sac. Persistent sac pressurization may result in continued aneurysm sac enlargement, the need for secondary interventions, and, in some cases, aneurysm rupture. These complications contribute substantially to the long-term follow-up burden and healthcare costs associated with EVAR.
Type II endoleaks are among the most common endoleak types observed following EVAR and occur when retrograde blood flow enters the aneurysm sac through aortic side branches, such as the inferior mesenteric artery or lumbar arteries. Patients with specific anatomical characteristics are known to be at increased risk for development of Type II endoleaks and subsequent aneurysm sac enlargement.
AneuFix Injectable Polymer is an investigational injectable polymer designed to fill the aneurysm sac at the time of EVAR and interrupt blood flow through aortic side branches communicating with the sac. The polymer is delivered into the aneurysm sac after endograft placement, where it cures in situ to form a durable implant. The approach is intended to provide more complete occlusion of the aneurysm sac environment and associated side-branch ostia compared with selective embolization techniques.
Previous clinical experience with the AneuFix technology, including pilot, feasibility, and Type II endoleak treatment studies, has demonstrated procedural feasibility and provided preliminary evidence supporting further evaluation in a randomized controlled study.
The SEAL-EVAR study is a prospective, multicenter, randomized controlled trial designed to evaluate whether adjunctive aneurysm sac filling with AneuFix Injectable Polymer, when used in combination with standard EVAR, improves clinical outcomes compared with standard EVAR alone in patients at increased risk of developing Type II endoleaks. The study will assess both safety and effectiveness outcomes, including freedom from Type II endoleak, prevention of aneurysm sac enlargement, and reduction in AAA-related reinterventions. Long-term follow-up will be performed to evaluate durability of treatment effects and continued safety.
The results of this study are intended to provide high-quality clinical evidence regarding the role of prophylactic aneurysm sac filling as an adjunct to EVAR and to support future clinical, regulatory, and health-economic evaluations of this treatment strategy.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Tjeerd Homsma, Msc.
- 電話番号：+31 (0)6 29078003
- メール：t.homsma@triple-med.com
研究場所
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-
North Holland
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Amsterdam、North Holland、オランダ、105 AZ
- Amsterdam UMC
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コンタクト：
- Arjan W.J. Hoksbergen, Dr.
- 電話番号：+31 (0) 650531007
- メール：a.hoksbergen@amsterdamumc.nl
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
-
Age over 22 years
-
Presence of an infrarenal AAA with a maximum diameter of at least 5 cm for women and 5.5 cm for men
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High risk of developing T2EL after the EVAR procedure, based on one or more of the following criteria observed on a preoperative CTA scan. High risk participants are those with:
- A patent inferior mesenteric artery with a luminal diameter at its origin >3 mm OR
- At least three pairs of patent lumbar arteries OR
- Two pairs of lumbar arteries and a median sacral artery or an accessory renal artery
-
Subject or legal caregiver's willingness and ability to comply with the requirements of this clinical study and provide written informed consent
Exclusion Criteria:
General
- Inability to provide informed consent.
- Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.
- Unable or unwilling to comply with study follow-up requirements.
- Prisoner or member of other vulnerable population
Anatomical
- Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.
- Aorto-Iliac aneurysms
- Aneurysm sac requiring more than 100ml of AneuFix Injectable Polymer to fill
- Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.
- Connective tissue disorder (e.g., Marfan's syndrome)
- Aneurysmal disease of the descending thoracic aorta
- Proximal abdominal aneurysm extent including or above the renal arteries
- Calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties
Procedural
- Use of endograft without support struts in the bifurcation (e.g. Endologix - Alto)
- Use of an aortic stent graft other than those specified for a particular site
- Planned off-label use of the chosen stent graft
- Use of fenestrated stent grafts or chimney techniques
- Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries
- Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries, except when the internal iliac artery pre-procedure is already occluded.
Medical History/Conditions
- Coagulopathy or uncontrolled bleeding disorder
- Serum creatinine level > 2.5 mg/dL
- Cerebrovascular accident within 3 months prior to the procedure
- Myocardial infarction and/or major heart surgery within 3 months prior to the procedure
- Atrial fibrillation that is not well rate controlled
- Life expectancy of <2 years post-procedure
- Known hypersensitivity or other contraindication to tantalum
- Active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC>11,000/mm3)
- A condition that inhibits radiographic visualization during the implantation procedure
- History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CTA with contrast for any reason.
- Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial
- Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial.
研究計画
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：防止
- 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 |
|---|---|
|
実験的：EVAR + AneuFix Injectable Polymer
Participants will undergo standard EVAR followed by delivery of AneuFix Injectable Polymer into the aneurysm sac according to the study procedure. The polymer is intended to fill the aneurysm sac and occlude blood flow pathways that may contribute to the development of Type II endoleaks. |
Injectable polymer intended for delivery into the abdominal aortic aneurysm sac during EVAR to provide aneurysm sac filling and occlusion of blood flow pathways associated with Type II endoleak formation. Endovascular placement of a commercially available stent graft to exclude the abdominal aortic aneurysm from systemic blood flow. |
|
アクティブコンパレータ：Standard EVAR
Participants will undergo standard EVAR according to the site's standard practice without adjunctive treatment with AneuFix Injectable Polymer. |
Endovascular placement of a commercially available stent graft to exclude the abdominal aortic aneurysm from systemic blood flow. |
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 |
|---|---|---|
|
Composite Treatment Success at 12 Months
時間枠：12 Months
|
Proportion of subjects achieving treatment success at 12 months, defined as single composite of:
|
12 Months
|
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Major Adverse Event (MAE) rate within the 30-day follow-up period after the procedure
時間枠：30 Days Post-Procedure
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Major Adverse Event (MAE) rate within the 30-day follow-up period after the procedure.
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30 Days Post-Procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Type II Endoleak (T2EL)
時間枠：1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure
|
Percentage of subjects with a persistent or recurrent Type II endoleak confirmed by imaging assessment. |
1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure
|
|
Incidence of Type I, III or IV Endoleak
時間枠：1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure
|
Percentage of subjects with a Type I, III or IV endoleak identified on imaging assessment. |
1 month, 6 months, 2 years, 3 years, 4 years, and 5 years Post-Procedure
|
|
Change in Aneurysm Sac Diameter
時間枠：2 years, 3 years, 4 years, and 5 years Post-Procedure
|
Change in maximum aneurysm sac diameter measured in millimeters (mm) compared with baseline. |
2 years, 3 years, 4 years, and 5 years Post-Procedure
|
|
Change in Aneurysm Sac Volume
時間枠：2 years, 3 years, 4 years, and 5 years Post-Procedure
|
Change in aneurysm sac volume measured in cubic centimeters (cm³) compared with baseline. |
2 years, 3 years, 4 years, and 5 years Post-Procedure
|
|
Aneurysm-Related Reintervention Rate
時間枠：Until the end of study (5 years)
|
Percentage of subjects requiring aneurysm-related reintervention. Reinterventions will be categorized as open surgical or endovascular procedures and the reason will be recorded. |
Until the end of study (5 years)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Hans Brom, Dr.、TripleMed B.V.
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- TripleMed 004
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The Clinical Investigation Plan does not include provisions for sharing individual participant data with external researchers. Study results will be reported through the Clinical Investigation Report and scientific publications.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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