Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair (ACE)
ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "
Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.
The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.
調査の概要
状態
詳細な説明
ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.
The aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Creteil、フランス、94 010
- Hôpital Henri Mondor
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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:
- Patients aged 50 years old or more (more than 80 possible depending on physiological age)
- Level 0, 1, or 2 of operative risk
- Abdominal aortic aneurysm with a diameter > or equal to 50 mm or > or equal to 40 mm if rapid growing (10 mm or more in a year), or painful, or saccular aneurysms, or aneurisms of common iliac arteries with a diameter equal or superior to 30 mm; or women with a diameter equal to 45 mm;
- Aortic neck superior or equal to 1.5 cm
- No stenosis superior or equal to 75% of the superior mesenteric artery
- Proximal neck angulation inferior to 80°
- Diameter of the iliac arteries compatible with introducer sheath
- Inform consent signed
Exclusion Criteria:
- Aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm
- Thrombus or major calcification in the neck
- Diameter of the iliac arteries not compatible with introducer sheath
- Level 3 of operative risk
- History of major iodine allergy (Quincke oedema, anaphylactic shock)
- Other comorbidity with life expectancy less than 6 months
- Follow up impossible during the trial
- Participation in another trial
- Inform consent not signed
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：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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アクティブコンパレータ：1
surgery - open repair
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Conventional repair consist in open repair.
Different types of surgery can be done : minimal incision aortic surgery (MIAS), transperitoneal approach (TPA), retroperitoneal repair, or conventional median laparotomy.
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実験的：2
endovascular procedure
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An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent.
It can be used for a variety of conditions involving the blood vessels, but most commonly to reinforce a weak spot in an artery called an aneurysm.
Over time, blood pressure and other factors can cause this weak area to bulge like a balloon and eventually enlarge and rupture.
The stent graft seals tightly with your artery above and below the aneurysm.
The graft is stronger than the weakened artery and allows blood to pass through it without pushing on the bulge.
Physicians typically use endovascular stent grafting to treat abdominal aortic aneurysms (AAAs).
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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 |
時間枠 |
|---|---|
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Death and major adverse events
時間枠：4 years
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4 years
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Minor adverse events (systemic vascular or non vascular complications)
時間枠：4 years
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4 years
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協力者と研究者
捜査官
- 主任研究者：Yann JOUSSET, MD、CHU Angers - Hôtel Dieu
- 主任研究者：Jean M Pernes, MD、Hopital Prive d'Antony
- 主任研究者：Pierre Y Meaulle, MD、Clinique mutualiste des Eaux Claires, Grenoble
- 主任研究者：Jean P Favre, MD、CHU Hôpital Nord, Saint-Etienne
- 主任研究者：Jacques Watelet, MD、Hôpital Charles Nicolle, Rouen
- 主任研究者：Patrick Lermusiaux, MD、CHRU -Hôpital Trousseau, Tours
- 主任研究者：Jean F Heautot, MD、CHU de Pontchaillou, Rennes
- 主任研究者：Mohamad KOUSSA, MD、Hôpital Cardiologique , Lille
- 主任研究者：Patrice BERGERON, MD、Hôpital St Joseph, Marseille
- 主任研究者：Philippe CHAILLOU, MD、Hôpital Nord Laennec, Nantes
- 主任研究者：Eric CHEYSSON, MD、Centre Hospitalier René Dubos, Pontoise
- 主任研究者：Arnaud DEMON, MD、CH de Valenciennes
- 主任研究者：Jean C PILLET, MD、Nouvelles Cliniques Nantaises, Nantes
- 主任研究者：Eric STEINMETZ, MD、CHU de Dijon - Hopital du Bocage
- 主任研究者：Michel LEVADE, MD、Clinique Pasteur Toulouse
- 主任研究者：Jean CARDON, MD、Clinique des Franciscaines, Nimes
- 主任研究者：Pierre-Edouard MAGNAN, MD、CHU Timone, Marseille
- 主任研究者：Michel Batt, MD、Hôpital St-Roch, Nice
- 主任研究者：Pierre GOUNY, MD、Hopital de la cavale blanche, Brest
- 主任研究者：Antoine Lucas, MD、Chu Pontchaillou
- スタディチェア：Jean P Becquemin, MD、Hopital Henri Mondor, Creteil
- スタディチェア：Marc Sapoval, MD、HEGP, Paris
出版物と役立つリンク
一般刊行物
- Lederle FA. Endovascular repair of abdominal aortic aneurysm--round two. N Engl J Med. 2005 Jun 9;352(23):2443-5. doi: 10.1056/NEJMe058126. No abstract available.
- Becquemin JP, Pillet JC, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P, Steinmetz E, Marzelle J; ACE trialists. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011 May;53(5):1167-1173.e1. doi: 10.1016/j.jvs.2010.10.124. Epub 2011 Jan 26.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。
Open repairの臨床試験
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University of California, San DiegoPatient-Centered Outcomes Research Institute; University of Massachusetts, Worcester; Palo Alto... と他の協力者完了
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Radboud University Medical CenterUniversity Medical Center Nijmegenわからない
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Western University, CanadaPanam Clinic募集
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African Wood IncAlupe University Collegeわからない