RIBS IV (Restenosis Intra-stent of Drug-eluting 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: NCT01239940
• Lead Sponsor: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular

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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-11
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27
• Primary Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 310

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

• 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 and eluted drug; E) Influence of clinical variables and restenosis patterns on outcome

Trial Locations

Locations (25)

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

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

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

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

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario Carlos Haya; 🇪🇸 Malaga, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Complejo Hospitalario de Toledo; 🇪🇸 Toledo, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

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

Hospital Universitario Infanta Cristina; 🇪🇸 Badajoz, Spain

Complejo Hospitalario de Torrecardenas; 🇪🇸 Almeria, Spain

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

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

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

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

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

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

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

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

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

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