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

NCT01239953 | Unknown Phase 4 DMC

• 1 other identifier: RIBS V
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 25

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.

Conditions

In-Stent Restenosis

Keywords

In-stent restenosis; Drug-eluting balloon; Drug-eluting stent; Angiography; Minimal lumen diameter

Outcome Measures

Primary Outcomes (1)

• Minimal lumen diameter

  Comparison of minimal lumen diameter at late angiographic follow-up (6-9 months) between the 2 treatment strategies (by quantitative coronary angiography)

  Late angiographic follow-up (6-9 months)

Secondary Outcomes (1)

• Combined clinical and angiographic end-points

  6-9 months, 1 year and 3 years

Study Arms (2)

Paclitaxel-eluting balloon

ACTIVE COMPARATOR

Paclitaxel-eluting balloon (SeQuent Please, B. Braun)

Device: Coronary angioplasty using the paclitaxel-eluting balloon

Everolimus-eluting stent

ACTIVE COMPARATOR

Everolimus-eluting stent (Xience Prime, Abbott Vascular)

Device: Coronary angioplasty using the everolimus-eluting stent

Interventions

Coronary angioplasty using the paclitaxel-eluting balloon DEVICE

Balloon angioplasty

Paclitaxel-eluting balloon

Coronary angioplasty using the everolimus-eluting stent DEVICE

Stent implantation

Everolimus-eluting stent

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• PATIENT:
• 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)

Sponsors & Collaborators

• Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular: lead
• Hospital San Carlos, Madrid: collaborator
• B.Braun Surgical SA: collaborator
• Abbott Medical Devices: collaborator

Study Sites (25)

Complejo Hospitalario Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

Location

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

Location

Complejo Hospitalario de Torrecardenas

Almería, Almeria, 04009, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, Badajoz, 06080, Spain

Location

Hospital Universitari Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

Location

Hospital Universitario de La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Carlos Haya

Málaga, Malaga, 29010, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, 29010, Spain

Location

Hospital Provincial de Navarra

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, 36204, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Complejo Hospitalario de Toledo

Toledo, Toledo, 45004, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

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• Alfonso F. Paclitaxel-Eluting Balloons for In-Stent Restenosis. Circulation 2010. In press.

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  BACKGROUND

• Alfonso F, Perez-Vizcayno MJ, Garcia Del Blanco B, Garcia-Touchard A, Lopez-Minguez JR, Masotti M, Zueco J, Melgares R, Mainar V, Moreno R, Dominguez A, Sanchis J, Bethencourt A, Moreu J, Cequier A, Marti V, Otaegui I, Bastante T, Gonzalo N, Jimenez-Quevedo P, Cardenas A, Fernandez C; under the auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology. Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials. Circ Cardiovasc Interv. 2016 Jul;9(7):e003479. doi: 10.1161/CIRCINTERVENTIONS.115.003479.

  PMID: 27412868 DERIVED

• Alfonso F, Perez-Vizcayno MJ, Garcia Del Blanco B, Otaegui I, Masotti M, Zueco J, Velaquez M, Sanchis J, Garcia-Touchard A, Lazaro-Garcia R, Moreu J, Bethencourt A, Cuesta J, Rivero F, Cardenas A, Gonzalo N, Jimenez-Quevedo P, Fernandez C; RIBS V Study Investigators. Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial. JACC Cardiovasc Interv. 2016 Jun 27;9(12):1246-1255. doi: 10.1016/j.jcin.2016.03.037. Epub 2016 Jun 20.

  PMID: 27339840 DERIVED

• Alfonso F, Perez-Vizcayno MJ, Cardenas A, Garcia Del Blanco B, Seidelberger B, Iniguez A, Gomez-Recio M, Masotti M, Velazquez MT, Sanchis J, Garcia-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, Lopez-Minguez JR, Moreu J, Marti V, Moreno R, Jimenez-Quevedo P, Gonzalo N, Fernandez C, Macaya C; RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014 Apr 15;63(14):1378-86. doi: 10.1016/j.jacc.2013.12.006. Epub 2014 Jan 8.

  PMID: 24412457 DERIVED

Study Officials

• Fernando Alfonso, MD, PhD

  Hospital San Carlos, Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital Universitario Clínico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 15, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Last Updated: February 27, 2012

Record last verified: 2012-02

Locations

ES (25)