Comparison of Drug Eluting Balloon and Drug Eluting Stent

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01539603

Acronym

DEBfirst

Enrollment

180

Registered

2012-02-27

Start date

2011-04-30

Completion date

2015-02-28

Last updated

2015-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, NSTEMI, Stable Angina, Unstable Angina

Keywords

drug eluting balloon, bare metal stent, drug eluting stent, coronary artery disease

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).

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.

Interventions

DEVICEDrug eluting balloon + Bare metal stent

PCI using Sequent Please and then Coroflex Blue

DEVICEdrug eluting stent (Zotarolimus-eluting stent)

conventional PCI using Endeavor Integrity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
in-segment late loss	9 month	angiographic in-segment late loss measure by QCA program

Secondary

Measure	Time frame	Description
stent thrombosis	9 month	any stent thrombosis
angiographic and procedure success	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.
MACE	9 month	death, MI and TVF

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026