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

This study has been completed.
Information provided by (Responsible Party):
Chang-Hwan Yoon, Seoul National University Bundang Hospital Identifier:
First received: February 21, 2012
Last updated: June 11, 2015
Last verified: June 2015
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).

Condition Intervention Phase
Coronary Artery Disease
Stable Angina
Unstable Angina
Device: Drug eluting balloon + Bare metal stent
Device: drug eluting stent (Zotarolimus-eluting stent)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • in-segment late loss [ Time Frame: 9 month ] [ Designated as safety issue: No ]
    angiographic in-segment late loss measure by QCA program

Secondary Outcome Measures:
  • stent thrombosis [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    any stent thrombosis

  • angiographic and procedure success [ Time Frame: 9 month ] [ Designated as safety issue: No ]

    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 [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
    death, MI and TVF

Enrollment: 180
Study Start Date: April 2011
Study Completion Date: February 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Endeavor integrity
  • Zotarolimus-eluting stent

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.


Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01539603

Korea, Republic of
Seoul National Universtiy Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Principal Investigator: In-Ho Chae, MD Seoul National University Bundang Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chang-Hwan Yoon, Assistant professor, Seoul National University Bundang Hospital Identifier: NCT01539603     History of Changes
Other Study ID Numbers: E-1104/061-001 
Study First Received: February 21, 2012
Last Updated: June 11, 2015
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Bundang Hospital:
drug eluting balloon
bare metal stent
drug eluting stent
coronary artery disease

Additional relevant MeSH terms:
Angina, Stable
Angina, Unstable
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Cardiovascular Diseases
Chest Pain
Heart Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases processed this record on May 26, 2016