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

NCT ID: NCT01239953

Last Updated: 2012-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31

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.

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.

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 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)

• 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

Fernando Alfonso, MD, PhD

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando Alfonso, MD, PhD

Role: STUDY_DIRECTOR

Hospital San Carlos, Madrid

Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Complejo Hospitalario de Torrecardenas

Almería, Almeria, Spain

Hospital Universitario Infanta Cristina

Badajoz, Badajoz, Spain

Hospital Universitari Son Dureta

Palma de Mallorca, Balearic Islands, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Barcelona, Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Hospital Universitario de La Princesa

Madrid, Madrid, Spain

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Carlos Haya

Málaga, Malaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, Spain

Hospital Provincial de Navarra

Pamplona, Navarre, Spain

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Complejo Hospitalario de Toledo

Toledo, Toledo, Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Hospital General Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

Countries

Spain

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Other Identifiers

RIBS V

Identifier Type: -

Identifier Source: org_study_id