RIBS V（裸金属支架的支架内再狭窄：紫杉醇洗脱球囊与依维莫司洗脱支架） (RIBS V)
2012年2月24日 更新者：Fernando Alfonso, MD, PhD、Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
RIBS V（裸金属支架的支架内再狭窄：紫杉醇洗脱球囊与依维莫司洗脱支架）。一项前瞻性、多中心和随机临床试验
裸金属支架再狭窄患者的治疗仍然是一个挑战。
本研究将评估哪种介入策略（紫杉醇洗脱球囊与依维莫司洗脱支架）在治疗裸金属支架再狭窄患者方面更胜一筹。
研究概览
详细说明
裸金属支架再狭窄患者的治疗仍然是主要的临床和技术挑战。 目前，药物洗脱支架广泛应用于这些患者的治疗。 最近，有人提出了紫杉醇洗脱球囊在这种临床环境中的价值。 然而，关于这种新球囊在裸金属支架再狭窄患者中的价值的观察数据很少。
这项前瞻性、多中心、随机临床试验将比较两种不同的介入策略（即紫杉醇洗脱球囊与依维莫司洗脱支架）治疗裸金属支架再狭窄患者的效果。
研究类型
介入性
注册 (实际的)
190
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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A Coruña、西班牙、15006
- Complejo Hospitalario Universitario A Coruña
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Alicante、西班牙、03010
- Hospital General Universitario de Alicante
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Almeria、西班牙、04009
- Complejo Hospitalario de Torrecardenas
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Badajoz、西班牙、06080
- Hospital Universitario Infanta Cristina
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Barcelona、西班牙、08036
- Hospital Clinic De Barcelona
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Barcelona、西班牙、08025
- Hospital de la Santa Creu i Sant Pau
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Barcelona、西班牙、08035
- Hospital Universitari Vall d'Hebron
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Granada、西班牙、18014
- Hospital Universitario Virgen de Las Nieves
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Madrid、西班牙、28040
- Hospital Clinico San Carlos
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Madrid、西班牙、28041
- Hospital Universitario 12 de Octubre
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Madrid、西班牙、28046
- Hospital Universitario La Paz
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Madrid、西班牙、28006
- Hospital Universitario de la Princesa
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Malaga、西班牙、29010
- Hospital Universitario Virgen de la Victoria
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Malaga、西班牙、29010
- Hospital Universitario Carlos Haya
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Toledo、西班牙、45004
- Complejo Hospitalario de Toledo
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Valencia、西班牙、46010
- Hospital Clinico Universitario de Valencia
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Valencia、西班牙、46014
- Hospital General Universitario de Valencia
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Zaragoza、西班牙、50009
- Hospital Universitario Miguel Servet
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Asturias
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Oviedo、Asturias、西班牙、33006
- Hospital Central de Asturias
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Barcelona
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L'Hospitalet de Llobregat、Barcelona、西班牙、08907
- Hospital Universitari de Bellvitge
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Cantabria
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Santander、Cantabria、西班牙、39008
- Hospital Universitario Marques de Valdecilla
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Illes Balears
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Palma de Mallorca、Illes Balears、西班牙、07014
- Hospital Universitari Son Dureta
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Madrid
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Majadahonda、Madrid、西班牙、28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Navarra
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Pamplona、Navarra、西班牙、31008
- Hospital Provincial de Navarra
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Pontevedra
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Vigo、Pontevedra、西班牙、36204
- Complejo Hospitalario Universitario de Vigo
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准：
病人：
- 年龄在 20 至 85 岁之间
- 签署知情同意书
- 接受晚期血管造影控制（6-9个月）
- 心绞痛和/或缺血的客观证据
病变：
- 支架内再狭窄（> 50% 可见）任何裸金属支架
- 先前支架位置的知识
排除标准：
病人：
- 纳入另一项临床研究方案
- 育龄妇女
- 严重相关的全身性疾病（包括肾或肝功能衰竭）
- 左心室射血分数严重降低（LVEF <25%）
- 影响寿命的疾病
- 近期心肌梗死（<7天）
- 前期BMS植入时间<1个月
- 晚期血管造影研究预计会遇到严重困难
病变：
- 初始支架实施过程中血管造影失败（残余狭窄> 50%）
- 支架内大血栓图像（> 血管直径）
- 曲折或 Ca + + 在之前的支架部署过程中有非常严重的困难
- 血管直径 <2 mm（目测）
- 再狭窄仅在支架“外部”（支架边缘不受影响）
- 完全闭塞再狭窄（100%，TIMI 0）
- 非常弥漫性再狭窄（> 30 mm 长度）
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：紫杉醇洗脱球囊
紫杉醇洗脱球囊 (SeQuent Please, B. Braun)
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球囊血管成形术
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有源比较器：依维莫司洗脱支架
依维莫司洗脱支架（Xience Prime、Abbott Vascular）
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支架植入
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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最小管腔直径
大体时间：晚期血管造影随访（6-9 个月）
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两种治疗策略（通过定量冠状动脉造影）在晚期血管造影随访（6-9 个月）时比较最小管腔直径
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晚期血管造影随访（6-9 个月）
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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联合临床和血管造影终点
大体时间：6-9个月、1年和3年
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A) 疗效结果： A1) 血管造影：1) 再狭窄率，2) 直径狭窄百分比，3) 急性增加，4) 晚期损失，5) 净增加 A2) 死亡、心肌梗死、靶血管血运重建和个体事件分析的综合 B) 安全结果：支架内血栓形成、出血事件。 C) 用于亚组分析的预先指定变量 (RIBS I) D) 分层（长度和边缘）。 支架类型 E) 临床变量和再狭窄模式对结果的影响 |
6-9个月、1年和3年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Fernando Alfonso, MD, PhD、Hospital San Carlos, Madrid
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.
- Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78. doi: 10.1016/S0140-6736(07)60314-6.
- Kimura T, Yokoi H, Nakagawa Y, Tamura T, Kaburagi S, Sawada Y, Sato Y, Yokoi H, Hamasaki N, Nosaka H, et al. Three-year follow-up after implantation of metallic coronary-artery stents. N Engl J Med. 1996 Feb 29;334(9):561-6. doi: 10.1056/NEJM199602293340903.
- Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
- Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. doi: 10.1161/01.cir.100.18.1872.
- Adamian M, Colombo A, Briguori C, Nishida T, Marsico F, Di Mario C, Albiero R, Moussa I, Moses JW. Cutting balloon angioplasty for the treatment of in-stent restenosis: a matched comparison with rotational atherectomy, additional stent implantation and balloon angioplasty. J Am Coll Cardiol. 2001 Sep;38(3):672-9. doi: 10.1016/s0735-1097(01)01458-9.
- Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, Lopez-Minguez JR, Angel J, Auge JM, Gomez-Recio M, Moris C, Seabra-Gomes R, Perez-Vizcayno MJ, Macaya C; Restenosis Intra-stent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. A randomized comparison of repeat stenting with balloon angioplasty in patients with in-stent restenosis. J Am Coll Cardiol. 2003 Sep 3;42(5):796-805. doi: 10.1016/s0735-1097(03)00852-0.
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- Alfonso F, Cequier A, Angel J, Marti V, Zueco J, Bethencourt A, Mantilla R, Lopez-Minguez JR, Gomez-Recio M, Moris C, Perez-Vizcayno MJ, Fernandez C, Macaya C, Seabra-Gomes R; Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) Investigators. Value of the American College of Cardiology/American Heart Association angiographic classification of coronary lesion morphology in patients with in-stent restenosis. Insights from the Restenosis Intra-stent Balloon angioplasty versus elective Stenting (RIBS) randomized trial. Am Heart J. 2006 Mar;151(3):681.e1-681.e9. doi: 10.1016/j.ahj.2005.10.014.
- Alfonso F, Perez-Vizcayno MJ, Hernandez R, Bethencourt A, Marti V, Lopez-Minguez JR, Angel J, Mantilla R, Moris C, Cequier A, Sabate M, Escaned J, Moreno R, Banuelos C, Suarez A, Macaya C; RIBS-II Investigators. A randomized comparison of sirolimus-eluting stent with balloon angioplasty in patients with in-stent restenosis: results of the Restenosis Intrastent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) trial. J Am Coll Cardiol. 2006 Jun 6;47(11):2152-60. doi: 10.1016/j.jacc.2005.10.078.
- Alfonso F, Perez-Vizcayno MJ, Hernandez R, Fernandez C, Escaned J, Banuelos C, Bethencourt A, Lopez-Minguez JR, Angel J, Cequier A, Sabate M, Moris C, Zueco J, Seabra-Gomes R; Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Stent Implantation (RIBS-I) and Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) Investigators. Sirolimus-eluting stents versus bare-metal stents in patients with in-stent restenosis: results of a pooled analysis of two randomized studies. Catheter Cardiovasc Interv. 2008 Oct 1;72(4):459-67. doi: 10.1002/ccd.21694.
- Alfonso F, Perez-Vizcayno MJ, Hernandez R, Bethencourt A, Marti V, Lopez-Minguez JR, Angel J, Iniguez A, Moris C, Cequier A, Sabate M, Escaned J, Jimenez-Quevedo P, Banuelos C, Suarez A, Macaya C; RIBS-II Investigators. Long-term clinical benefit of sirolimus-eluting stents in patients with in-stent restenosis results of the RIBS-II (Restenosis Intra-stent: Balloon angioplasty vs. elective sirolimus-eluting Stenting) study. J Am Coll Cardiol. 2008 Nov 11;52(20):1621-7. doi: 10.1016/j.jacc.2008.08.025.
- Baz JA, Pinar E, Albarran A, Mauri J; Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology. Spanish Cardiac Catheterization and Coronary Intervention Registry. 17th official report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2007). Rev Esp Cardiol. 2008 Dec;61(12):1298-314. doi: 10.1016/s1885-5857(09)60057-8. English, Spanish.
- Alfonso F, Perez-Vizcayno MJ, Cruz A, Garcia J, Jimenez-Quevedo P, Escaned J, Hernandez R. Treatment of patients with in-stent restenosis. EuroIntervention. 2009 May;5 Suppl D:D70-8.
- Pinar E, Albarran A, Baz JA, Mauri J. [Update on interventional cardiology]. Rev Esp Cardiol. 2009 Jan;62 Suppl 1:101-16. doi: 10.1016/s0300-8932(09)70045-4. Spanish.
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- Alfonso F, Perez-Vizcayno MJ, Hernandez R, Goicolea J, Fernandez-Ortiz A, Escaned J, Banuelos C, Fernandez C, Macaya C. Long-term outcome and determinants of event-free survival in patients treated with balloon angioplasty for in-stent restenosis. Am J Cardiol. 1999 Apr 15;83(8):1268-70, A9. doi: 10.1016/s0002-9149(99)00071-5.
- Alfonso F, Suarez A, Perez L, Sabate M, Moreno R, Banuelos C. Intravascular ultrasound in patients with challenging in-stent restenosis: importance of precise stent visualization. J Interv Cardiol. 2006 Apr;19(2):153-9. doi: 10.1111/j.1540-8183.2006.00123.x.
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- Reimers B, Moussa I, Akiyama T, Tucci G, Ferraro M, Martini G, Blengino S, Di Mario C, Colombo A. Long-term clinical follow-up after successful repeat percutaneous intervention for stent restenosis. J Am Coll Cardiol. 1997 Jul;30(1):186-92. doi: 10.1016/s0735-1097(97)00142-3.
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- Albiero R, Silber S, Di Mario C, Cernigliaro C, Battaglia S, Reimers B, Frasheri A, Klauss V, Auge JM, Rubartelli P, Morice MC, Cremonesi A, Schofer J, Bortone A, Colombo A; RESCUT Investigators. Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosis: results of the restenosis cutting balloon evaluation trial (RESCUT). J Am Coll Cardiol. 2004 Mar 17;43(6):943-9. doi: 10.1016/j.jacc.2003.09.054.
- Alfonso F. Should we use the cutting balloon in patients with in-stent restenosis? J Am Coll Cardiol. 2004 Dec 21;44(12):2416; author reply 2417. doi: 10.1016/j.jacc.2004.09.022. No abstract available.
- Mehran R, Dangas G, Mintz GS, Waksman R, Abizaid A, Satler LF, Pichard AD, Kent KM, Lansky AJ, Stone GW, Leon MB. Treatment of in-stent restenosis with excimer laser coronary angioplasty versus rotational atherectomy: comparative mechanisms and results. Circulation. 2000 May 30;101(21):2484-9. doi: 10.1161/01.cir.101.21.2484.
- Strauss BH, Umans VA, van Suylen RJ, de Feyter PJ, Marco J, Robertson GC, Renkin J, Heyndrickx G, Vuzevski VD, Bosman FT, et al. Directional atherectomy for treatment of restenosis within coronary stents: clinical, angiographic and histologic results. J Am Coll Cardiol. 1992 Dec;20(7):1465-73. doi: 10.1016/0735-1097(92)90438-s.
- Sharma SK, Kini A, Mehran R, Lansky A, Kobayashi Y, Marmur JD. Randomized trial of Rotational Atherectomy Versus Balloon Angioplasty for Diffuse In-stent Restenosis (ROSTER). Am Heart J. 2004 Jan;147(1):16-22. doi: 10.1016/j.ahj.2003.07.002.
- vom Dahl J, Dietz U, Haager PK, Silber S, Niccoli L, Buettner HJ, Schiele F, Thomas M, Commeau P, Ramsdale DR, Garcia E, Hamm CW, Hoffmann R, Reineke T, Klues HG. Rotational atherectomy does not reduce recurrent in-stent restenosis: results of the angioplasty versus rotational atherectomy for treatment of diffuse in-stent restenosis trial (ARTIST). Circulation. 2002 Feb 5;105(5):583-8. doi: 10.1161/hc0502.103347.
- Sabate M, Costa MA, Kozuma K, Kay IP, van der Giessen WJ, Coen VL, Ligthart JM, Serrano P, Levendag PC, Serruys PW. Geographic miss: a cause of treatment failure in radio-oncology applied to intracoronary radiation therapy. Circulation. 2000 May 30;101(21):2467-71. doi: 10.1161/01.cir.101.21.2467.
- Waksman R, Ajani AE, White RL, Chan R, Bass B, Pichard AD, Satler LF, Kent KM, Torguson R, Deible R, Pinnow E, Lindsay J. Five-year follow-up after intracoronary gamma radiation therapy for in-stent restenosis. Circulation. 2004 Jan 27;109(3):340-4. doi: 10.1161/01.CIR.0000109488.62415.01. Epub 2004 Jan 19.
- Alfonso F, Sabate M. Sirolimus-eluting stents vs brachytherapy for restenosis. JAMA. 2006 Oct 18;296(15):1837-8; author reply 1838. doi: 10.1001/jama.296.15.1837-c. No abstract available.
- Moris C, Alfonso F, Lambert JL, Espolita A, Barriales V, Rodriguez V, Barriales R, Cortina A. Stenting for coronary dissection after balloon dilation of in-stent restenosis: stenting a previously stented site. Am Heart J. 1996 Apr;131(4):834-6. doi: 10.1016/s0002-8703(96)90298-7. No abstract available.
- Alfonso F, Cequier A, Zueco J, Moris C, Suarez CP, Colman T, Esplugas E, Perez-Vizcayno MJ, Fernandez C, Macaya C. Stenting the stent: initial results and long-term clinical and angiographic outcome of coronary stenting for patients with in-stent restenosis. Am J Cardiol. 2000 Feb 1;85(3):327-32. doi: 10.1016/s0002-9149(99)00741-9.
- Mintz GS, Hoffmann R, Mehran R, Pichard AD, Kent KM, Satler LF, Popma JJ, Leon MB. In-stent restenosis: the Washington Hospital Center experience. Am J Cardiol. 1998 Apr 9;81(7A):7E-13E. doi: 10.1016/s0002-9149(98)00190-8.
- Shiran A, Mintz GS, Waksman R, Mehran R, Abizaid A, Kent KM, Pichard AD, Satler LF, Popma JJ, Leon MB. Early lumen loss after treatment of in-stent restenosis: an intravascular ultrasound study. Circulation. 1998 Jul 21;98(3):200-3. doi: 10.1161/01.cir.98.3.200.
- Alfonso F, Garcia P, Fleites H, Pimentel G, Sabate M, Hernandez R, Escaned J, Banuelos C, Perez-Vizcayno MJ, Moreno R, Macaya C. Repeat stenting for the prevention of the early lumen loss phenomenon in patients with in-stent restenosis. Angiographic and intravascular ultrasound findings of a randomized study. Am Heart J. 2005 Feb;149(2):e1-8. doi: 10.1016/j.ahj.2004.06.022.
- Alfonso F, Hernandez C, Perez-Vizcayno MJ, Hernandez R, Fernandez-Ortiz A, Escaned J, Banuelos C, Sabate M, Sanmartin M, Fernandez C, Macaya C. Fate of stent-related side branches after coronary intervention in patients with in-stent restenosis. J Am Coll Cardiol. 2000 Nov 1;36(5):1549-56. doi: 10.1016/s0735-1097(00)00927-x.
- Alfonso F, Pérez-Vizcayno MJ, Gómez-Recio M, Insa L, Calvo I, Hernández JM, Bullones JA, Hernández R, Escaned J, Macaya C, Gama-Ribeiro V, Leitao-Marques A; Restenosis Intrastent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. Implications of the
- Alfonso F. Optimal implantation strategies using drug-eluting stents for in-stent restenosis: do we know the answer? Circulation. 2004 Sep 14;110(11):e302. doi: 10.1161/01.CIR.0000141457.02676.FD. No abstract available.
- Dibra A, Kastrati A, Alfonso F, Seyfarth M, Perez-Vizcayno MJ, Mehilli J, Schomig A. Effectiveness of drug-eluting stents in patients with bare-metal in-stent restenosis: meta-analysis of randomized trials. J Am Coll Cardiol. 2007 Feb 6;49(5):616-23. doi: 10.1016/j.jacc.2006.10.049. Epub 2006 Dec 4.
- Alfonso F. Drug-eluting stents and in-stent restenosis. JAMA. 2005 Apr 20;293(15):1855; author reply 1855-6. doi: 10.1001/jama.293.15.1855-a. No abstract available.
- Rodriguez AE, Granada JF, Rodriguez-Alemparte M, Vigo CF, Delgado J, Fernandez-Pereira C, Pocovi A, Rodriguez-Granillo AM, Schulz D, Raizner AE, Palacios I, O'Neill W, Kaluza GL, Stone G; ORAR II Investigators. Oral rapamycin after coronary bare-metal stent implantation to prevent restenosis: the Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study. J Am Coll Cardiol. 2006 Apr 18;47(8):1522-9. doi: 10.1016/j.jacc.2005.12.052. Epub 2006 Mar 29.
- Alfonso F. Paclitaxel-Eluting Balloons for In-Stent Restenosis. Circulation 2010. In press.
- Alfonso F, Garcia J, Perez-Vizcayno MJ, Hernando L, Hernandez R, Escaned J, Jimenez-Quevedo P, Banuelos C, Macaya C. New stent implantation for recurrences after stenting for in-stent restenosis: implications of a third metal layer in human coronary arteries. J Am Coll Cardiol. 2009 Sep 8;54(11):1036-8. doi: 10.1016/j.jacc.2009.04.082. No abstract available.
- Alfonso F, Perez-Vizcayno MJ, Garcia Del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Masotti M, Zueco J, Melgares R, Mainar V, Moreno R, Dominguez A, Sanchis J, Bethencourt A, Moreu J, Cequier A, Marti V, Otaegui I, Bastante T, Gonzalo N, Jimenez-Quevedo P, Cardenas A, Fernandez C; under the auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology. Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials. Circ Cardiovasc Interv. 2016 Jul;9(7):e003479. doi: 10.1161/CIRCINTERVENTIONS.115.003479.
- Stone GW, for the SPIRIT IV Investigators.. One year clinical results of SPIRIT IV (A Prospective, Randomized Trial Comparing an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease). Clinical Trials. TCT 2009. San Francisco, USA, Septiembre 2009.
- Alfonso F, Perez-Vizcayno MJ, Garcia Del Blanco B, Otaegui I, Masotti M, Zueco J, Velaquez M, Sanchis J, Garcia-Touchard A, Lazaro-Garcia R, Moreu J, Bethencourt A, Cuesta J, Rivero F, Cardenas A, Gonzalo N, Jimenez-Quevedo P, Fernandez C; RIBS V Study Investigators. Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial. JACC Cardiovasc Interv. 2016 Jun 27;9(12):1246-1255. doi: 10.1016/j.jcin.2016.03.037. Epub 2016 Jun 20.
- Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Seidelberger B, Iniguez A, Gomez-Recio M, Masotti M, Velazquez MT, Sanchis J, Garcia-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, Lopez-Minguez JR, Moreu J, Marti V, Moreno R, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014 Apr 15;63(14):1378-86. doi: 10.1016/j.jacc.2013.12.006. Epub 2014 Jan 8.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年1月1日
初级完成 (预期的)
2012年7月1日
研究注册日期
首次提交
2010年11月12日
首先提交符合 QC 标准的
2010年11月12日
首次发布 (估计)
2010年11月15日
研究记录更新
最后更新发布 (估计)
2012年2月27日
上次提交的符合 QC 标准的更新
2012年2月24日
最后验证
2012年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.