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

NCT01239940 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2011-06-27

No results posted yet for this study

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.

Conditions

  • In-stent Restenosis

Interventions

DEVICE

Coronary angioplasty using the paclitaxel-eluting balloon

Balloon angioplasty

DEVICE

Coronary angioplasty using the Everolimus-eluting stent

Stent implantation

Sponsors & Collaborators

  • Hospital San Carlos, Madrid

    collaborator OTHER

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Fundación Médica para la Investigación y Desarrollo en el Area Cardiovascular

    lead OTHER

Principal Investigators

  • Fernando Alfonso, MD, PhD · Hospital San Carlos, Madrid

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01239940 on ClinicalTrials.gov