RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

NCT ID: NCT01239940

Last Updated: 2011-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

Brief 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.

Detailed 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.

Conditions

In-stent Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Paclitaxel-eluting balloon

Paclitaxel-eluting balloon (SeQuent Please, B. Braun)

Group Type: ACTIVE_COMPARATOR

Coronary angioplasty using the paclitaxel-eluting balloon

Intervention Type: DEVICE

Balloon angioplasty

Everolimus-eluting stent

Everolimus-eluting stent (Xience Prime, Abbott Vascular)

Group Type: ACTIVE_COMPARATOR

Coronary angioplasty using the Everolimus-eluting stent

Intervention Type: DEVICE

Stent implantation

Interventions

Coronary angioplasty using the paclitaxel-eluting balloon

Balloon angioplasty

Intervention Type: DEVICE

Coronary angioplasty using the Everolimus-eluting stent

Stent implantation

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital San Carlos, Madrid

OTHER

Sponsor Role: collaborator

B.Braun Surgical SA

INDUSTRY

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular

OTHER

Sponsor Role: lead

Responsible Party

Hospital Universitario Clinico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit

Principal Investigators

Fernando Alfonso, MD, PhD

Role: STUDY_DIRECTOR

Hospital San Carlos, Madrid

Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Site Status: RECRUITING

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Site Status: RECRUITING

Complejo Hospitalario de Torrecardenas

Almería, Almeria, Spain

Site Status: RECRUITING

Hospital Universitario Infanta Cristina

Badajoz, Badajoz, Spain

Site Status: RECRUITING

Hospital Universitari Son Dureta

Palma de Mallorca, Balearic Islands, Spain

Site Status: RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Hospital Universitari Vall d´Hebron

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status: RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Site Status: RECRUITING

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Site Status: RECRUITING

Hospital Universitario Carlos Haya

Málaga, Malaga, Spain

Site Status: RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, Spain

Site Status: RECRUITING

Hospital Provincial de Navarra

Pamplona, Navarre, Spain

Site Status: RECRUITING

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Site Status: RECRUITING

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status: RECRUITING

Complejo Hospitalario de Toledo

Toledo, Toledo, Spain

Site Status: RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Site Status: RECRUITING

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Site Status: RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Nicolas Vazquez, MD

Role: primary

0034981178031

Vicente Mainar, MD

Role: primary

0034965938561

Rosa Lazaro, MD,

Role: primary

+34950016989

Jose R Lopez-Minguez, MD

Role: primary

0034924218125

Armando Bethencourt, MD

Role: primary

0034971175476

Vicens Marti, MD

Role: primary

0034935565851

Joan Angel, MD

Role: primary

0034934893000

Monica Masotti, MD

Role: primary

0034932275519

Angel Cequier, MD

Role: primary

0034932607539

Javier Zueco, MD

Role: primary

0034942202744

Rafael Melgares, MD

Role: primary

0034958020564

Bernhard Seidelberger, MD

Role: primary

0034915202200

Fernnado Alfonso, MD

Role: primary

falf@hotmail.com

0034913303289

Maria T Velazquez, MD

Role: primary

0034913908440

Raul Moreno, MD

Role: primary

0034917277000

Javier Goicolea, MD

Role: primary

0034911917408

Cristobal Urbano, MD

Role: primary

0034951290000

Jose M Hernandez, MD

Role: primary

0034951032000

Roman Lezaun, MD

Role: primary

0034848422345

Andres Iñiguez, MD

Role: primary

0034986811163

Raquel del Valle, MD

Role: primary

0034985106112

Jose Moreu, MD

Role: primary

+34925269188

Vicent Bodi, MD

Role: primary

0034963862658

Francisco Pomar, MD

Role: primary

0034961972000

Maria Cruz Ferrer, MD, PhD

Role: primary

+34976562565

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Alfonso F, Perez-Vizcayno MJ, Garcia Del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Sabate M, Zueco J, Melgares R, Hernandez R, Moreno R, Dominguez A, Sanchis J, Moris C, Moreu J, Cequier A, Romaguera R, Rivero F, Cuesta J, Gonzalo N, Jimenez-Quevedo P, Cardenas A, Fernandez C; Spanish Society of Cardiology. Usefulness of Drug-Eluting Balloons for Bare-Metal and Drug-Eluting In-Stent Restenosis (from the RIBS IV and V Randomized Trials). Am J Cardiol. 2017 Apr 1;119(7):983-990. doi: 10.1016/j.amjcard.2016.12.006. Epub 2017 Jan 5.

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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.

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Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Benedicto A, Masotti M, Zueco J, Iniguez A, Velazquez M, Moreno R, Mainar V, Dominguez A, Pomar F, Melgares R, Rivero F, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS IV Study Investigators (under auspices of Interventional Cardiology Working Group of Spanish Society of Cardiology). A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents: The RIBS IV Randomized Clinical Trial. J Am Coll Cardiol. 2015 Jul 7;66(1):23-33. doi: 10.1016/j.jacc.2015.04.063.

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Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Rivero F, Masotti M, Zueco J, Cequier A, Moris C, Fernandez-Ortiz A, Escaned J, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; Restenosis Intra-stent: drug-eluting Balloon vs. everolimus-eluting Stent (RIBS IV) Study Investigators (under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology). Rationale and design of the RIBS IV randomised clinical trial (drug-eluting balloons versus everolimus-eluting stents for patients with drug-eluting stent restenosis). EuroIntervention. 2015 Jul;11(3):336-42. doi: 10.4244/EIJY14M09_07.

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Other Identifiers

RIBS IV

Identifier Type: -

Identifier Source: org_study_id