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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Universitari Vall d´Hebron Recruiting
Barcelona, Spain, 08035
Contact: Joan Angel, MD    0034934893000      
Principal Investigator: Joan Angel, MD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Vicens Marti, MD    0034935565851      
Principal Investigator: Vicens Marti, 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 Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Fernnado Alfonso, MD    0034913303289    falf@hotmail.com   
Principal Investigator: Fernando Alfonso, MD, PhD         
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Maria T Velazquez, MD    0034913908440      
Principal Investigator: Maria T Velazquez, MD         
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Contact: Bernhard Seidelberger, MD    0034915202200      
Principal Investigator: Bernhard Seidelberger, MD         
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Raul Moreno, MD    0034917277000      
Principal Investigator: Raul Moreno, MD         
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 San Carlos, Madrid
B.Braun Surgical SA
Abbott Vascular
Investigators
Study Director: Fernando Alfonso, MD, PhD Hospital 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
Paclitaxel
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014