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

Primary Purpose

Coronary Artery Disease, Stable Angina, Unstable Angina

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Drug eluting balloon + Bare metal stent
drug eluting stent (Zotarolimus-eluting stent)
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring drug eluting balloon, bare metal stent, drug eluting stent, coronary artery disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National Universtiy Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DEB-BMS

Drug eluting stent

Arm Description

Drug eluting balloon + Bare metal stent

conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)

Outcomes

Primary Outcome Measures

in-segment late loss
angiographic in-segment late loss measure by QCA program

Secondary Outcome Measures

stent thrombosis
any stent thrombosis
angiographic and procedure success
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.
MACE
death, MI and TVF

Full Information

First Posted
February 21, 2012
Last Updated
June 11, 2015
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01539603
Brief Title
Comparison of Drug Eluting Balloon and Drug Eluting Stent
Acronym
DEBfirst
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Stable Angina, Unstable Angina, NSTEMI
Keywords
drug eluting balloon, bare metal stent, drug eluting stent, coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEB-BMS
Arm Type
Experimental
Arm Description
Drug eluting balloon + Bare metal stent
Arm Title
Drug eluting stent
Arm Type
Active Comparator
Arm Description
conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)
Intervention Type
Device
Intervention Name(s)
Drug eluting balloon + Bare metal stent
Other Intervention Name(s)
Sequent Please (B.Braun, drug eluting balloon), Coroflex Blue (B.Braun, bare metal stent)
Intervention Description
PCI using Sequent Please and then Coroflex Blue
Intervention Type
Device
Intervention Name(s)
drug eluting stent (Zotarolimus-eluting stent)
Other Intervention Name(s)
Endeavor integrity, Zotarolimus-eluting stent
Intervention Description
conventional PCI using Endeavor Integrity
Primary Outcome Measure Information:
Title
in-segment late loss
Description
angiographic in-segment late loss measure by QCA program
Time Frame
9 month
Secondary Outcome Measure Information:
Title
stent thrombosis
Description
any stent thrombosis
Time Frame
9 month
Title
angiographic and procedure success
Description
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.
Time Frame
9 month
Title
MACE
Description
death, MI and TVF
Time Frame
9 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Ho Chae, MD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National Universtiy Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28480650
Citation
Chae IH, Yoon CH, Park JJ, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ. Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial. J Korean Med Sci. 2017 Jun;32(6):933-941. doi: 10.3346/jkms.2017.32.6.933.
Results Reference
derived
PubMed Identifier
23394404
Citation
Park SD, Yoon CH, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ, Chae IH. Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial. Trials. 2013 Feb 8;14:38. doi: 10.1186/1745-6215-14-38. Erratum In: Trials. 2017 May 23;18(1):232.
Results Reference
derived

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Comparison of Drug Eluting Balloon and Drug Eluting Stent

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