Comparison of Drug Eluting Balloon and Drug Eluting Stent

Phase 2

Completed

• Conditions: Stable Angina; Unstable Angina; NSTEMI; Coronary Artery Disease
• Interventions: Device: drug eluting stent (Zotarolimus-eluting stent); Device: Drug eluting balloon + Bare metal stent

• Registration Number: NCT01539603
• Lead Sponsor: 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-02-27
• Primary Completion: 2014-12
• Study Completion: 2015-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-11
• Last Update Posted: 2015-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• De novo lesion
• 2.5mm =< Reference diameter =< 4mm
• Lesion length =< 28mm
• Type A, B1/B2 lesion

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug eluting stent	drug eluting stent (Zotarolimus-eluting stent)	conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)
DEB-BMS	Drug eluting balloon + Bare metal stent	Drug eluting balloon + Bare metal stent

Primary Outcome Measures

Name	Time	Method
in-segment late loss	9 month	angiographic in-segment late loss measure by QCA program

Secondary Outcome Measures

Name	Time	Method
stent thrombosis	9 month	any stent thrombosis
MACE	9 month	death, MI and TVF
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.

Trial Locations

Locations (1)

Seoul National Universtiy Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of