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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01539603
Recruitment Status : Completed
First Posted : February 27, 2012
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):
Chang-Hwan Yoon, Seoul National University Bundang Hospital

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).

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

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  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

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:
  • Endeavor integrity
  • Zotarolimus-eluting stent

Primary Outcome Measures :
  1. in-segment late loss [ Time Frame: 9 month ]
    angiographic in-segment late loss measure by QCA program

Secondary Outcome Measures :
  1. stent thrombosis [ Time Frame: 9 month ]
    any stent thrombosis

  2. 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.

  3. MACE [ Time Frame: 9 month ]
    death, MI and TVF

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: February 27, 2012    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: June 2015

Keywords provided by Chang-Hwan Yoon, Seoul National University Bundang Hospital:
drug eluting balloon
bare metal stent
drug eluting stent
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Stable
Angina, Unstable
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs