Clinical trial NCT01239953: RIBS V (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)
Official title: RIBS V (Restenosis Intra-stent of Bare Metal 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: 190
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 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.

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)

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 Marques 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 Clinico 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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