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

This study is currently recruiting participants.
Verified April 2014 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Chang-Hwan Yoon, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01539603
First received: February 21, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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
NSTEMI
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


Estimated Enrollment: 180
Study Start Date: April 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539603

Contacts
Contact: Chang-Hwan Yoon, MD +82 31 787 7052 kunson2@snu.ac.kr
Contact: In-Ho Chae, MD +82 31 787 3238 ihchae@snu.ac.kr

Locations
Korea, Republic of
Seoul National Universtiy Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Chang-Hwan Yoon, MD    +82 31 787 7052    kunson2@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: In-Ho Chae, MD Seoul National University Bundang Hospital
  More Information

No publications provided by Seoul National University Bundang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chang-Hwan Yoon, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01539603     History of Changes
Other Study ID Numbers: E-1104/061-001
Study First Received: February 21, 2012
Last Updated: April 4, 2014
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 Pectoris
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 17, 2014