RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

• Sponsor: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01239953
• Collaborator: Hospital San Carlos, Madrid (Other), B.Braun Surgical SA (Industry), Abbott Medical Devices (Industry)
• Enrollment: 190
• Locations: 25
• Arms: 2
• Patients Per Site: 7.6

Study Details

Study Description

Brief Summary

Treatment of patients with bare metal stent restenosis remains a challenge. This study will assess which interventional strategy (paclitaxel-eluting balloon vs everolimus-eluting stent) is superior in the treatment of patients suffering from bare metal stent restenosis.

Condition or Disease	Intervention/Treatment	Phase
In-Stent Restenosis	Device: Coronary angioplasty using the paclitaxel-eluting balloon; Device: Coronary angioplasty using the everolimus-eluting stent	Phase 4

Detailed Description

Treatment of patients with bare metal stent restenosis remains a major clinical and technical challenge. Currently, drug-eluting stents are widely used in the management of these patients. Recently, the value of the paclitaxel-eluting balloon in this clinical setting has been suggested. However, there is only scarce observational data on the value of this new balloon in patients with bare metal stent restenosis.

This prospective, multicenter, randomized clinical trial will compare two different interventional strategies (namely, paclitaxel-eluting balloon vs everolimus-eluting stent) in the treatment of patients with bare metal stent restenosis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Paclitaxel-eluting balloon Paclitaxel-eluting balloon (SeQuent Please, B. Braun)	Device: Coronary angioplasty using the paclitaxel-eluting balloon; Balloon angioplasty
Active Comparator: Everolimus-eluting stent Everolimus-eluting stent (Xience Prime, Abbott Vascular)	Device: Coronary angioplasty using the everolimus-eluting stent; Stent implantation

Outcome Measures

Primary Outcome Measures

1. Minimal lumen diameter [Late angiographic follow-up (6-9 months)]

   Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography)

Secondary Outcome Measures

1. Combined clinical and angiographic end-points [6-9 months, 1 year and 3 years]

   A) Efficacy outcomes: A1) Angiographic: 1) Restenosis rate, 2) % diameter stenosis, 3) acute gain, 4) late loss, 5) net gain A2) Composite of death, myocardial infarction, target vessel revascularization and analysis of individual events B) Safety Outcomes: Stent thrombosis, Bleeding episodes. C) Pre-specified variables for subgroup analysis (RIBS I) D) Stratification (length and edge). Type of stent E) Influence of clinical variables and restenosis patterns on outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

PATIENT:

• Age between 20 and 85 years

• Signed informed consent

• Acceptance of late angiographic control (6-9 months)

• Angina and / or objective evidence of ischemia

LESION:

• In-Stent restenosis (> 50% visual) any bare metal stent

• Knowledge of prior stent location

Exclusion Criteria:

PATIENT:

• Inclusion in another clinical research protocol

• Women of childbearing age

• Severe associated systemic disease (including renal or liver failure)

• Severe depression of left ventricular ejection fraction (LVEF <25%)

• Disease that affects life expectancy

• Recent myocardial infarction ( <7 days)

• Time of implantation of the previous BMS <1 month

• Severe difficulties expected for late angiographic study

LESION:

• Angiographic failure during implementation of initial stent(residual stenosis> 50%)

• Image of large thrombus in-stent (> vessel diameter)

• Tortuosity or Ca + + with very severe difficulties during prior stent deployment

• Vessel diameter <2 mm (visual estimate)

• Restenosis only "outside" the stent (The edge of the stent is not affected)

• Completely occlusive restenosis (100%, TIMI 0)

• Very diffuse restenosis (> 30 mm length)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Central de Asturias	Oviedo	Asturias	Spain	33006
2	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona	Spain	08907
3	Hospital Universitario Marques de Valdecilla	Santander	Cantabria	Spain	39008
4	Hospital Universitari Son Dureta	Palma de Mallorca	Illes Balears	Spain	07014
5	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid	Spain	28222
6	Hospital Provincial de Navarra	Pamplona	Navarra	Spain	31008
7	Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra	Spain	36204
8	Complejo Hospitalario Universitario A Coruña	A Coruña		Spain	15006
9	Hospital General Universitario de Alicante	Alicante		Spain	03010
10	Complejo Hospitalario de Torrecardenas	Almeria		Spain	04009
11	Hospital Universitario Infanta Cristina	Badajoz		Spain	06080
12	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08025
13	Hospital Universitari Vall d'Hebron	Barcelona		Spain	08035
14	Hospital Clinic de Barcelona	Barcelona		Spain	08036
15	Hospital Universitario Virgen de las Nieves	Granada		Spain	18014
16	Hospital Universitario de La Princesa	Madrid		Spain	28006
17	Hospital Clinico San Carlos	Madrid		Spain	28040
18	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
19	Hospital Universitario La Paz	Madrid		Spain	28046
20	Hospital Universitario Carlos Haya	Malaga		Spain	29010
21	Hospital Universitario Virgen de la Victoria	Malaga		Spain	29010
22	Complejo Hospitalario de Toledo	Toledo		Spain	45004
23	Hospital Clinico Universitario de Valencia	Valencia		Spain	46010
24	Hospital General Universitario de Valencia	Valencia		Spain	46014
25	Hospital Universitario Miguel Servet	Zaragoza		Spain	50009

Sponsors and Collaborators

• Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
• Hospital San Carlos, Madrid
• B.Braun Surgical SA
• Abbott Medical Devices

Investigators

• Study Director: Fernando Alfonso, MD, PhD, Hospital San Carlos, Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Alfonso F, Augé JM, Zueco J, Bethencourt A, López-Mínguez JR, Hernández JM, Bullones JA, Calvo I, Esplugas E, Pérez-Vizcayno MJ, Moreno R, Fernández C, Hernández R, Gama-Ribeiro V; RIBS Investigators. Long-term results (three to five years) of the Restenosis Intrastent: Balloon angioplasty versus elective Stenting (RIBS) randomized study. J Am Coll Cardiol. 2005 Sep 6;46(5):756-60.
• Alfonso F, Cequier A, Angel J, Martí V, Zueco J, Bethencourt A, Mantilla R, López-Minguez JR, Gómez-Recio M, Morís C, Perez-Vizcayno MJ, Fernández 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.
• Alfonso F, Cequier A, Zueco J, Morís C, Suárez CP, Colman T, Esplugas E, Pérez-Vizcayno MJ, Fernández 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.
• Alfonso F, García J, Pérez-Vizcayno MJ, Hernando L, Hernandez R, Escaned J, Jiménez-Quevedo P, Bañuelos 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.
• Alfonso F, García P, Fleites H, Pimentel G, Sabaté M, Hernández R, Escaned J, Bañuelos C, Pérez-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.
• Alfonso F, Hernández C, Pérez-Vizcayno MJ, Hernández R, Fernández-Ortíz A, Escaned J, Bañuelos C, Sabaté M, Sanmartín M, Fernández 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.
• Alfonso F, Melgares R, Mainar V, Lezaún R, Vázquez N, Tascón J, Pomar F, Cequier A, Angel J, Pérez-Vizcayno MJ, Sabaté M, Bañuelos C, Fernández C, García JM; Restensois Intra-stent: Ballon angioplasty versus elective Stenting (RIBS) Investigators. Therapeutic implications of in-stent restenosis located at the stent edge. Insights from the restenosis intra-stent balloon angioplasty versus elective stenting (RIBS) randomized trial. Eur Heart J. 2004 Oct;25(20):1829-35.
• Alfonso F, Pérez-Vizcayno MJ, Cruz A, García J, Jimenez-Quevedo P, Escaned J, Hernandez R. Treatment of patients with in-stent restenosis. EuroIntervention. 2009 May;5 Suppl D:D70-8. Review.
• 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, Pérez-Vizcayno MJ, Hernández R, Bethencourt A, Martí V, López-Mínguez JR, Angel J, Iñiguez A, Morís C, Cequier A, Sabaté M, Escaned J, Jiménez-Quevedo P, Bañuelos C, Suárez 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.
• Alfonso F, Pérez-Vizcayno MJ, Hernandez R, Bethencourt A, Martí V, López-Mínguez JR, Angel J, Mantilla R, Morís C, Cequier A, Sabaté M, Escaned J, Moreno R, Bañuelos C, Suárez 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.
• Alfonso F, Pérez-Vizcayno MJ, Hernandez R, Fernandez C, Escaned J, Bañuelos C, Bethencourt A, López-Mínguez JR, Angel J, Cequier A, Sabaté M, Morís 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, Pérez-Vizcayno MJ, Hernández R, Goicolea J, Fernández-Ortíz A, Escaned J, Bañuelos C, Fernández 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.
• Alfonso F, Sabate M. Sirolimus-eluting stents vs brachytherapy for restenosis. JAMA. 2006 Oct 18;296(15):1837-8; author reply 1838.
• Alfonso F, Suárez A, Pérez L, Sabaté M, Moreno R, Bañuelos C. Intravascular ultrasound in patients with challenging in-stent restenosis: importance of precise stent visualization. J Interv Cardiol. 2006 Apr;19(2):153-9.
• Alfonso F, Zueco J, Cequier A, Mantilla R, Bethencourt A, López-Minguez JR, Angel J, Augé JM, Gómez-Recio M, Morís 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.
• Alfonso F. Drug-eluting stents and in-stent restenosis. JAMA. 2005 Apr 20;293(15):1855; author reply 1855-6.
• 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.
• Alfonso F. Paclitaxel-Eluting Balloons for In-Stent Restenosis. Circulation 2010. In press.
• 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.
• Bauters C, Banos JL, Van Belle E, Mc Fadden EP, Lablanche JM, Bertrand ME. Six-month angiographic outcome after successful repeat percutaneous intervention for in-stent restenosis. Circulation. 1998 Feb 3;97(4):318-21.
• Baz JA, Pinar E, Albarrán 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. English, Spanish.
• Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Jüni 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.
• Dibra A, Kastrati A, Alfonso F, Seyfarth M, Pérez-Vizcayno MJ, Mehilli J, Schömig 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. Epub 2006 Dec 4.
• Hernández RA, Macaya C, Iñiguez A, Alfonso F, Goicolea J, Fernandez-Ortiz A, Zarco P. Midterm outcome of patients with asymptomatic restenosis after coronary balloon angioplasty. J Am Coll Cardiol. 1992 Jun;19(7):1402-9.
• 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. Epub 2006 Mar 12.
• Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schühlen H, Schmitt C, Dirschinger J, Schömig A; ISAR-DESIRE Study Investigators. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005 Jan 12;293(2):165-71.
• 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.
• Lopez-Palop R, Pinar E, Lozano I, Saura D, Picó F, Valdés M. Utility of the fractional flow reserve in the evaluation of angiographically moderate in-stent restenosis. Eur Heart J. 2004 Nov;25(22):2040-7.
• 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.
• 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.
• Mehran R, Mintz GS, Popma JJ, Pichard AD, Satler LF, Kent KM, Griffin J, Leon MB. Mechanisms and results of balloon angioplasty for the treatment of in-stent restenosis. Am J Cardiol. 1996 Sep 15;78(6):618-22.
• 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. Review.
• Morís 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.
• Pinar E, Albarrán A, Baz JA, Mauri J. [Update on interventional cardiology]. Rev Esp Cardiol. 2009 Jan;62 Suppl 1:101-16. Review. Spanish.
• 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.
• 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. Epub 2006 Mar 29.
• Sabaté 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.
• Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13.
• 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.
• 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.
• Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006 Mar 15;295(11):1253-63. Epub 2006 Mar 12.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Epub 2004 Jan 19.

• Responsible Party: Fernando Alfonso, MD, PhD, Hospital Universitario Clínico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
• ClinicalTrials.gov Identifier: NCT01239953
• Other Study ID Numbers: RIBS V
• First Posted: Nov 15, 2010
• Last Update Posted: Feb 27, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Fernando Alfonso, MD, PhD, Hospital Universitario Clínico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit, Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular: In-stent restenosis; Drug-eluting balloon; Drug-eluting stent; Angiography; Minimal lumen diameter
• Additional relevant MeSH terms: Paclitaxel; Everolimus

Study Results

No Results Posted as of Feb 27, 2012