Comparison of Drug Eluting Balloon and Drug Eluting Stent (DEBfirst)

June 11, 2015 updated by: Chang-Hwan Yoon, Seoul National University Bundang Hospital

Comparison of Drug-Eluting Balloon First and Then Bare Metal Stent With Drug-eluting Stent for Treatment of de Novo Lesions (DEB First): A Randomized Controlled Single Center Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis.

We think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 463-707
        • Seoul National Universtiy Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • De novo lesion
  • 2.5mm =< Reference diameter =< 4mm
  • Lesion length =< 28mm
  • Type A, B1/B2 lesion

Exclusion Criteria:

  • ST-segment elevation MI
  • Reference diameter < 2.5mm or > 4mm
  • Bifurcation lesion
  • Type C lesion
  • history of AMI or stroke within 1 year F. chronic renal disease (Cr > 2mg/dL)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DEB-BMS
Drug eluting balloon + Bare metal stent
Device: Drug eluting balloon + Bare metal stent
PCI using Sequent Please and then Coroflex Blue
Other Names:
  • Sequent Please (B.Braun, drug eluting balloon)
  • Coroflex Blue (B.Braun, bare metal stent)
Active Comparator: Drug eluting stent
conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)
Device: drug eluting stent (Zotarolimus-eluting stent)
conventional PCI using Endeavor Integrity
Other Names:
  • Zotarolimus-eluting stent
  • Endeavor integrity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-segment late loss
Time Frame: 9 month
angiographic in-segment late loss measure by QCA program
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 9 month
death, MI and TVF
9 month
stent thrombosis
Time Frame: 9 month
any stent thrombosis
9 month
angiographic and procedure success
Time Frame: 9 month

Angiographic success denotes that residual diameter stenosis is less than 10% without complication such as coronarhy dissection or thrombosis.

Procedural success means that adequate DEB+BMS or DES delivery to the target lesion without geographic miss.
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: In-Ho Chae, MD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Estimate)

June 12, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1104/061-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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