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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01239940
Other study ID # RIBS IV
Secondary ID
Status Recruiting
Phase Phase 4
First received November 12, 2010
Last updated June 23, 2011
Start date January 2010

Study information

Verified date November 2010
Source Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial Summary

Treatment of patients with drug-eluting 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 drug-eluting stent restenosis.


Description:

Treatment of patients with drug-eluting 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 drug-eluting 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 drug-eluting stent restenosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 310
Est. completion date
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 85 Years
Eligibility 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 drug-eluting 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 DES <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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Coronary angioplasty using the paclitaxel-eluting balloon
Balloon angioplasty
Coronary angioplasty using the Everolimus-eluting stent
Stent implantation

Locations

Country Name City State
Spain Complejo Hospitalario Universitario A Coruña A Coruña
Spain Hospital General Universitario de Alicante Alicante
Spain Complejo Hospitalario de Torrecardenas Almeria
Spain Hospital Universitario Infanta Cristina Badajoz
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Universitari Vall d´Hebron Barcelona
Spain Hospital Universitario Virgen de las Nieves Granada
Spain Hospital Universitari de Bellvitge L´Hospitalet de Llobregat Barcelona
Spain Hospital Clínico San Carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Majadahonda Madrid
Spain Hospital Universitario Carlos Haya Malaga
Spain Hospital Universitario Virgen de la Victoria Malaga
Spain Hospital Central de Asturias Oviedo Asturias
Spain Hospital Universitari Son Dureta Palma de Mallorca Illes Balears
Spain Hospital Provincial de Navarra Pamplona Navarra
Spain Hospital Universitario Marqués de Valdecilla Santander Cantabria
Spain Complejo Hospitalario de Toledo Toledo
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital General Universitario de Valencia Valencia
Spain Complejo Hospitalario Universitario de Vigo Vigo Pontevedra
Spain Hospital Universitario Miguel Servet Zaragoza

Sponsors (4)

Lead Sponsor Collaborator
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular Abbott Vascular, B.Braun Surgical SA, Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (60)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 "watermelon seeding" phenomenon during coronary interventions for in-stent restenosis. Catheter Cardiovasc Interv. 2005 Dec;66(4):521-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Alfonso F, Sabate M. Sirolimus-eluting stents vs brachytherapy for restenosis. JAMA. 2006 Oct 18;296(15):1837-8; author reply 1838. — View Citation

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. — View Citation

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. — View Citation

Alfonso F. Drug-eluting stents and in-stent restenosis. JAMA. 2005 Apr 20;293(15):1855; author reply 1855-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Byrne R, Iijima R, Mehilli J, Pache J, Schulz S, Schömig A, Kastrati A. [Treatment of Paclitaxel-eluting stent restenosis with sirolimus-eluting stent implantation: angiographic and clinical outcomes]. Rev Esp Cardiol. 2008 Nov;61(11):1134-9. Spanish. — View Citation

Colombo A, Latib A. [Treatment of drug-eluting stent restenosis with another drug-eluting stent: do not fail the second time!]. Rev Esp Cardiol. 2008 Nov;61(11):1120-2. Spanish. — View Citation

Cosgrave J, Melzi G, Corbett S, Biondi-Zoccai GG, Babic R, Airoldi F, Chieffo A, Sangiorgi GM, Montorfano M, Michev I, Carlino M, Colombo A. Repeated drug-eluting stent implantation for drug-eluting stent restenosis: the same or a different stent. Am Heart J. 2007 Mar;153(3):354-9. — View Citation

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. — View Citation

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. — View Citation

Garg S, Smith K, Torguson R, Okabe T, Slottow TL, Steinberg DH, Roy P, Xue Z, Gevorkian N, Satler LF, Kent KM, Suddath WO, Pichard AD, Waksman R. Treatment of drug-eluting stent restenosis with the same versus different drug-eluting stent. Catheter Cardiovasc Interv. 2007 Jul 1;70(1):9-14. — View Citation

Gonzalo N, Serruys PW, Okamura T, van Beusekom HM, Garcia-Garcia HM, van Soest G, van der Giessen W, Regar E. Optical coherence tomography patterns of stent restenosis. Am Heart J. 2009 Aug;158(2):284-93. doi: 10.1016/j.ahj.2009.06.004. — View Citation

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ISAR-DESIRE-II. TCT 2009. Abstract.

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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. — View Citation

Lemos PA, van Mieghem CA, Arampatzis CA, Hoye A, Ong AT, McFadden E, Sianos G, van der Giessen WJ, de Feyter PJ, van Domburg RT, Serruys PW. Post-sirolimus-eluting stent restenosis treated with repeat percutaneous intervention: late angiographic and clinical outcomes. Circulation. 2004 Jun 1;109(21):2500-2. Epub 2004 May 17. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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Wong SC, Baim DS, Schatz RA, Teirstein PS, King SB 3rd, Curry RC Jr, Heuser RR, Ellis SG, Cleman MW, Overlie P, et al. Immediate results and late outcomes after stent implantation in saphenous vein graft lesions: the multicenter U.S. Palmaz-Schatz stent experience. The Palmaz-Schatz Stent Study Group. J Am Coll Cardiol. 1995 Sep;26(3):704-12. — View Citation

* Note: There are 60 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Minimal lumen diameter Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography) Late angiographic follow-up (6-9 months) No
Secondary Combined clinical and angiographic end-points 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 and eluted drug
E) Influence of clinical variables and restenosis patterns on outcome
6-9 months, 1 year and 3 years Yes
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