The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 12, 2010
First Posted Date  ICMJE November 15, 2010
Last Update Posted Date June 27, 2011
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2010)		 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2010)		 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent)
Official Title  ICMJE RIBS IV (Restenosis Intra-stent of Drug-eluting Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent). A Prospective, Multicenter and Randomized Clinical Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE In-stent Restenosis
Intervention  ICMJE
  • Device: Coronary angioplasty using the paclitaxel-eluting balloon
    Balloon angioplasty
  • Device: Coronary angioplasty using the Everolimus-eluting stent
    Stent implantation
Study Arms  ICMJE
  • Active Comparator: Paclitaxel-eluting balloon
    Paclitaxel-eluting balloon (SeQuent Please, B. Braun)
    Intervention: Device: Coronary angioplasty using the paclitaxel-eluting balloon
  • Active Comparator: Everolimus-eluting stent
    Everolimus-eluting stent (Xience Prime, Abbott Vascular)
    Intervention: Device: Coronary angioplasty using the Everolimus-eluting stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 12, 2010)		 310
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01239940
Other Study ID Numbers  ICMJE RIBS IV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Fernando Alfonso, MD, PhD, Hospital Universitario Clinico San Carlos, Madrid. Cardiovascular Institute. Cardiac Department. Interventional Cardiology Unit
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Hospital San Carlos, Madrid
  • B.Braun Surgical SA
  • Abbott Medical Devices
Investigators  ICMJE
Study Director: Fernando Alfonso, MD, PhD Hospital San Carlos, Madrid
PRS Account Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular
Verification Date November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP