Comparison of Drug Eluting Balloon and Drug Eluting Stent

NCT01539603 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2015-06-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).

Conditions

Interventions

DEVICE

Drug eluting balloon + Bare metal stent

PCI using Sequent Please and then Coroflex Blue

DEVICE

drug eluting stent (Zotarolimus-eluting stent)

conventional PCI using Endeavor Integrity

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Principal Investigators

  • In-Ho Chae, MD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • South Korea

Study Locations

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Entities

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 NCT01539603 on ClinicalTrials.gov