RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hospital Clinico San Carlos, Madrid
B.Braun Surgical SA
Abbott Vascular
Information provided by:
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
ClinicalTrials.gov Identifier:
NCT01239940
First received: November 12, 2010
Last updated: June 23, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
In-stent Restenosis
Device: Coronary angioplasty using the paclitaxel-eluting balloon
Device: Coronary angioplasty using the Everolimus-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular:

Primary Outcome Measures:
  • Minimal lumen diameter [ Time Frame: Late angiographic follow-up (6-9 months) ] [ Designated as safety issue: No ]
    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:
  • Combined clinical and angiographic end-points [ Time Frame: 6-9 months, 1 year and 3 years ] [ Designated as safety issue: Yes ]

    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



Estimated Enrollment: 310
Study Start Date: January 2010
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paclitaxel-eluting balloon
Paclitaxel-eluting balloon (SeQuent Please, B. Braun)
Device: Coronary angioplasty using the paclitaxel-eluting balloon
Balloon angioplasty
Active Comparator: Everolimus-eluting stent
Everolimus-eluting stent (Xience Prime, Abbott Vascular)
Device: Coronary angioplasty using the Everolimus-eluting stent
Stent implantation

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239940

Locations
Spain
Hospital Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33006
Contact: Raquel del Valle, MD    0034985106112      
Principal Investigator: Raquel del Valle, MD         
Hospital Universitari de Bellvitge Recruiting
L´Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Angel Cequier, MD    0034932607539      
Principal Investigator: Angel Cequier, MD         
Hospital Universitario Marqués de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Contact: Javier Zueco, MD    0034942202744      
Principal Investigator: Javier Zueco, MD         
Hospital Universitari Son Dureta Recruiting
Palma de Mallorca, Illes Balears, Spain, 07014
Contact: Armando Bethencourt, MD    0034971175476      
Principal Investigator: Armando Bethencourt, MD         
Hospital Universitario Puerta de Hierro Majadahonda Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Javier Goicolea, MD    0034911917408      
Principal Investigator: Javier Goicolea, MD         
Hospital Provincial de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Roman Lezaun, MD    0034848422345      
Principal Investigator: Roman Lezaun, MD         
Complejo Hospitalario Universitario de Vigo Recruiting
Vigo, Pontevedra, Spain, 36200
Contact: Andres Iñiguez, MD    0034986811163      
Principal Investigator: Andres Iñiguez, MD         
Complejo Hospitalario Universitario A Coruña Recruiting
A Coruña, Spain, 15006
Contact: Nicolas Vazquez, MD    0034981178031      
Principal Investigator: Nicolas Vazquez, MD         
Hospital General Universitario de Alicante Recruiting
Alicante, Spain, 03010
Contact: Vicente Mainar, MD    0034965938561      
Principal Investigator: Vicente Mainar, MD         
Complejo Hospitalario de Torrecardenas Recruiting
Almeria, Spain, 04009
Contact: Rosa Lazaro, MD,    +34950016989      
Principal Investigator: Rosa Lazaro, MD         
Hospital Universitario Infanta Cristina Recruiting
Badajoz, Spain, 06080
Contact: Jose R Lopez-Minguez, MD    0034924218125      
Principal Investigator: Jose R Lopez-Minguez, MD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Vicens Marti, MD    0034935565851      
Principal Investigator: Vicens Marti, MD         
Hospital Universitari Vall d´Hebron Recruiting
Barcelona, Spain, 08035
Contact: Joan Angel, MD    0034934893000      
Principal Investigator: Joan Angel, MD         
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Monica Masotti, MD    0034932275519      
Principal Investigator: Monica Masotti, MD         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Rafael Melgares, MD    0034958020564      
Principal Investigator: Rafael Melgares, MD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Maria T Velazquez, MD    0034913908440      
Principal Investigator: Maria T Velazquez, MD         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Raul Moreno, MD    0034917277000      
Principal Investigator: Raul Moreno, MD         
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Contact: Bernhard Seidelberger, MD    0034915202200      
Principal Investigator: Bernhard Seidelberger, MD         
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Fernnado Alfonso, MD    0034913303289    falf@hotmail.com   
Principal Investigator: Fernando Alfonso, MD, PhD         
Hospital Universitario Carlos Haya Recruiting
Malaga, Spain, 29010
Contact: Cristobal Urbano, MD    0034951290000      
Principal Investigator: Cristobal Urbano, MD         
Hospital Universitario Virgen de la Victoria Recruiting
Malaga, Spain, 29010
Contact: Jose M Hernandez, MD    0034951032000      
Principal Investigator: Jose M Hernandez, MD         
Complejo Hospitalario de Toledo Recruiting
Toledo, Spain, 45004
Contact: Jose Moreu, MD    +34925269188      
Principal Investigator: Jose Moreu, MD         
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Vicent Bodi, MD    0034963862658      
Principal Investigator: Vicent Bodi, MD         
Hospital General Universitario de Valencia Recruiting
Valencia, Spain, 46014
Contact: Francisco Pomar, MD    0034961972000      
Principal Investigator: Francisco Pomar, MD         
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact: Maria Cruz Ferrer, MD, PhD    +34976562565      
Principal Investigator: Maria Cruz Ferrer, MD, PhD         
Sponsors and Collaborators
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Hospital Clinico San Carlos, Madrid
B.Braun Surgical SA
Abbott Vascular
Investigators
Study Director: Fernando Alfonso, MD, PhD Hospital Clinico San Carlos, Madrid
  More Information

Publications:
Alfonso F, Pérez-Vizcayno MJ, Cruz A, García J, Jimenez-Quevedo P, Escaned J, Hernandez R. Treatment of patients with in-stent restenosis. EuroIntervention. 2009 May;5 Suppl D:D70-8.
Alfonso F, Pérez-Vizcayno MJ, Hernandez R, Fernandez C, Escaned J, Bañuelos C, Bethencourt A, López-Mínguez JR, Angel J, Cequier A, Sabaté M, Morís C, Zueco J, Seabra-Gomes R; Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Stent Implantation (RIBS-I) and Restenosis Intra-Stent: Balloon Angioplasty Versus Elective Sirolimus-Eluting Stenting (RIBS-II) Investigators. Sirolimus-eluting stents versus bare-metal stents in patients with in-stent restenosis: results of a pooled analysis of two randomized studies. Catheter Cardiovasc Interv. 2008;72:459-67.
Stone GW, for the SPIRIT IV Investigators. One year clinical results of SPIRIT IV (A Prospective, Randomized Trial Comparing an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease). Clinical Trials. TCT 2009. San Francisco, USA, Septiembre 2009.

Responsible Party: Fernando Alfonso, MD, PhD, Hospital Universitario Clinico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit
ClinicalTrials.gov Identifier: NCT01239940     History of Changes
Other Study ID Numbers: RIBS IV
Study First Received: November 12, 2010
Last Updated: June 23, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular:
In-stent restenosis
Drug-eluting balloon
Drug-eluting stent
Angiography
Minimal lumen diameter

Additional relevant MeSH terms:
Everolimus
Sirolimus
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 14, 2014