Clinical trial NCT01239940: RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)
Official title: RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: In-stent Restenosis
Keywords: In-stent restenosis
Drug-eluting balloon
Drug-eluting stent
Angiography
Minimal lumen diameter
Lead sponsor: Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Sponsor class: OTHER
Collaborators: name: Hospital San Carlos, Madrid
name: B.Braun Surgical SA
name: Abbott Medical Devices
First posted: 2010-11-15
Enrollment: 310
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Minimal lumen diameter
timeFrame: Late angiographic follow-up (6-9 months)
Secondary outcomes:
measure: Combined clinical and angiographic end-points
timeFrame: 6-9 months, 1 year and 3 years
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: L´Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Dureta
state: Illes Balears
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Pamplona
country: Spain
facility: Hospital Provincial de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Pontevedra
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Almeria
country: Spain
facility: Complejo Hospitalario de Torrecardenas
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Universitario Carlos Haya
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Toledo
country: Spain
facility: Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Fernando Alfonso, MD, PhD
role: STUDY_DIRECTOR
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