Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
A Multicenter, Randomized Study of the Sirolimus-Eluting Bx VELOCITY® BALLOON Expandable Stent vs. Intravascular Brachytherapy in the Treatment of Patients With In-Stent Restenotic Coronary Artery Lesions
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Rochester
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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:
1. The patient has an in-stent restenosis of > 50% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement ( 4 weeks). Lesions must meet ISR Classification I-III.
2. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. The diagnosis of angina pectoris is defined by Canadian Cardiovascular Society Classification (CCS I, II, III, or IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II) OR patients with documented silent ischemia;
3. The study target lesion must be located in an in-stent restenotic native coronary artery measuring > 2.75mm and 3.5mm in diameter and > 15mm and 40mm in length to allow treatment with a maximum of three 18mm stents. The target lesion must have undergone coronary interventional treatment > 4 weeks previously. Patients with one or more prior percutaneous coronary interventions at the target lesion are acceptable candidates.
4. The vessel 1cm distal to the target lesion is > 2.5mm in diameter;
5. Ejection Fraction must be > 40%;
6. The study target lesion cannot be located in a vessel containing a second lesion requiring treatment at the time of the procedure.
7. Male or non-pregnant female patients > 18 years of age inclusive. NOTE: Females of child-bearing potential must have a negative pregnancy test (urine or serum) prior to enrollment and must use birth control for 6 months.
Exclusion Criteria:
- The study target lesion has definite or possible thrombus present by angiographic criteria.
- The patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment.
- Impaired renal function (Serum creatinine > 2.0mg/dl);
- The patient has unstable angina classified as Braunwald III B or C, or is having peri infarction angina.
- The left ventricular ejection fraction is < 40%.
- The target vessel has previously sustained a perforation.
- Totally occluded vessel (TIMI 0 level);
- Prior stent within 5mm of target lesion;
- There is a total occlusion of the restenosed-stent (ISR Classification IV) prior to the interventional procedure.
- Has an ostial target lesion;
- Significant (> 50%) in-stent restenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
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 |
---|---|
実験的:1
サイファーBxベロシティ
|
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
|
アクティブコンパレータ:2
Brachytherapy
|
Brachytherapy
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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 |
---|---|
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.
時間枠:9 months post-procedure.
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9 months post-procedure.
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
処置後 6 か月および 9 か月での標的病変血行再建術 (TLR)。
時間枠:術後6ヶ月と9ヶ月
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術後6ヶ月と9ヶ月
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処置後 6 か月および 9 か月での標的血管血行再建術 (TVR)。
時間枠:術後6ヶ月と9ヶ月
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術後6ヶ月と9ヶ月
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Angiographic in-lesion and in-stent binary restenosis (³ 50% diameter stenosis) at 6 months post-procedure (by QCA).
時間枠:6 months post-procedure
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6 months post-procedure
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Post-procedure and six-month in-stent and in-lesion percent diameter stenosis (%DS) and late loss at 6 months post-procedure (by QCA) - [analysis at 6 months chosen so that results from the GAMMA Trial can be used].
時間枠:6 months post-procedure
|
6 months post-procedure
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Post-procedure and six-month in-stent and in-lesion minimum lumen diameter (MLD) (by QCA).
時間枠:Post-procedure and at six-month
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Post-procedure and at six-month
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Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-proce
時間枠:30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
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30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
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Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of patients conducted at 5-7 investigational centers.
時間枠:post-procedure and six months
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post-procedure and six months
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Cost associated with the index hospitalization, length of stay, and repeat hospitalizations during the 12 mo post-procedure follow-up.
時間枠:12 mo post-procedure
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12 mo post-procedure
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Rate of late thrombosis
時間枠:Throughout study
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Throughout study
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協力者と研究者
スポンサー
捜査官
- 主任研究者:David R. Holmes, Jr., MD、Mayo Clinic - Rochester, Minnesota
出版物と役立つリンク
一般刊行物
- Holmes DR Jr, Teirstein P, Satler L, Sketch M, O'Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA; SISR Investigators. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA. 2006 Mar 15;295(11):1264-73. doi: 10.1001/jama.295.11.1264. Epub 2006 Mar 12.
- Holmes DR Jr, Teirstein PS, Satler L, Sketch MH Jr, Popma JJ, Mauri L, Wang HP, Schleckser PA, Cohen SA; SISR Investigators. 3-year follow-up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):439-48. doi: 10.1016/j.jcin.2008.05.010.
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。
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