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Completed

NCT Number: NCT01539603

Comparison of Drug Eluting Balloon and Drug Eluting Stent

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).

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Unstable Angina Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National Universtiy Bundang Hospital

Seongnam, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Drug eluting balloon + Bare metal stent

Device

PCI using Sequent Please and then Coroflex Blue

Other names: Sequent Please (B.Braun, drug eluting balloon), Coroflex Blue (B.Braun, bare metal stent)

drug eluting stent (Zotarolimus-eluting stent)

Device

conventional PCI using Endeavor Integrity

Other names: Endeavor integrity, Zotarolimus-eluting stent

Primary outcomes

  1. in-segment late loss

    Time frame: 9 month

    angiographic in-segment late loss measure by QCA program

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study 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

Acronym: DEBfirst

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Feb 27, 2012
Registry last updated
Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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