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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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
Oviedo, Asturias, Spain, 33006
Hospital Universitari de Bellvitge
L´Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Universitari Son Dureta
Palma de Mallorca, Illes Balears, Spain, 07014
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
Hospital Provincial de Navarra
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain, 36200
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Complejo Hospitalario de Torrecardenas
Almeria, Spain, 04009
Hospital Universitario Infanta Cristina
Badajoz, Spain, 06080
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Universitari Vall d´Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Carlos Haya
Malaga, Spain, 29010
Hospital Universitario Virgen de la Victoria
Malaga, Spain, 29010
Complejo Hospitalario de Toledo
Toledo, Spain, 45004
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
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. 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):
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:
Paclitaxel
Albumin-Bound Paclitaxel
Everolimus
Sirolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on December 02, 2016