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

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ClinicalTrials.gov Identifier: NCT01239940
Recruitment Status : Unknown
Verified November 2010 by Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular.
Recruitment status was:  Recruiting
First Posted : November 15, 2010
Last Update Posted : June 27, 2011
Sponsor:
Collaborators:
Hospital San Carlos, Madrid
B.Braun Surgical SA
Abbott Medical Devices
Information provided by:
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2010
Estimated Primary Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Minimal lumen diameter [ Time Frame: Late angiographic follow-up (6-9 months) ]
    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 :
  1. Combined clinical and angiographic end-points [ Time Frame: 6-9 months, 1 year and 3 years ]

    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



Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239940


Locations
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Sponsors and Collaborators
Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Hospital San Carlos, Madrid
B.Braun Surgical SA
Abbott Medical Devices
Investigators
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Study Director: Fernando Alfonso, MD, PhD Hospital San Carlos, Madrid
More Information
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Publications:
Alfonso F, Pérez-Vizcayno MJ, Gómez-Recio M, Insa L, Calvo I, Hernández JM, Bullones JA, Hernández R, Escaned J, Macaya C, Gama-Ribeiro V, Leitao-Marques A; Restenosis Intrastent: Balloon Angioplasty Versus Elective Stenting (RIBS) Investigators. Implications of the
Alfonso F. Paclitaxel-Eluting Balloons for In-Stent Restenosis. Circulation 2010. In press.
ISAR-DESIRE-II. TCT 2009. Abstract.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fernando Alfonso, MD, PhD, Hospital Universitario Clinico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit
ClinicalTrials.gov Identifier: NCT01239940    
Other Study ID Numbers: RIBS IV
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: November 2010
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:
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Paclitaxel
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs