NCT01539603

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started Apr 2011

Typical duration for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

3.7 years

First QC Date

February 21, 2012

Last Update Submit

June 11, 2015

Conditions

Coronary Artery DiseaseStable AnginaUnstable AnginaNSTEMI

Keywords

drug eluting balloonbare metal stentdrug eluting stentcoronary artery disease

Outcome Measures

Primary Outcomes (1)

  • in-segment late loss

    angiographic in-segment late loss measure by QCA program

    9 month

Secondary Outcomes (3)

  • stent thrombosis

    9 month

  • angiographic and procedure success

    9 month

  • MACE

    9 month

Study Arms (2)

DEB-BMS

EXPERIMENTAL

Drug eluting balloon + Bare metal stent

Device: Drug eluting balloon + Bare metal stent

Drug eluting stent

ACTIVE COMPARATOR

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

Device: drug eluting stent (Zotarolimus-eluting stent)

Interventions

Drug eluting balloon + Bare metal stentDEVICE

PCI using Sequent Please and then Coroflex Blue

Also known as: Sequent Please (B.Braun, drug eluting balloon), Coroflex Blue (B.Braun, bare metal stent)
DEB-BMS
drug eluting stent (Zotarolimus-eluting stent)DEVICE

conventional PCI using Endeavor Integrity

Also known as: Endeavor integrity, Zotarolimus-eluting stent
Drug eluting stent

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Universtiy Bundang Hospital

Seongnam, 463-707, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 28480650DERIVED

  • 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.

    PMID: 23394404DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAngina, StableAngina, UnstableNon-ST Elevated Myocardial Infarction

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial InfarctionInfarctionIschemiaPathologic ProcessesNecrosis

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • In-Ho Chae, MD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 21, 2012

First Posted

February 27, 2012

Study Start

April 1, 2011

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

KR(1)