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

Phase 4

• Conditions: In-Stent Restenosis
• Interventions: Device: Coronary angioplasty using the everolimus-eluting stent; Device: Coronary angioplasty using the paclitaxel-eluting balloon

• Registration Number: NCT01239953
• Lead Sponsor: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-24
• Last Update Posted: 2012-02-27
• Primary Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus-eluting stent	Coronary angioplasty using the everolimus-eluting stent	Everolimus-eluting stent (Xience Prime, Abbott Vascular)
Paclitaxel-eluting balloon	Coronary angioplasty using the paclitaxel-eluting balloon	Paclitaxel-eluting balloon (SeQuent Please, B. Braun)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (25)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitari Son Dureta; 🇪🇸 Palma de Mallorca, Illes Balears, Spain

Complejo Hospitalario Universitario A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario Puerta de Hierro Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Provincial de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Carlos Haya; 🇪🇸 Malaga, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Complejo Hospitalario de Torrecardenas; 🇪🇸 Almeria, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Complejo Hospitalario de Toledo; 🇪🇸 Toledo, Spain

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Complejo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Pontevedra, Spain