Comparison of Drug Eluting Balloon and Drug Eluting Stent

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Stable Angina, Unstable Angina, NSTEMI

Intervention / Treatment
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* Device: Drug eluting balloon + Bare metal stent
* Device: drug eluting stent (Zotarolimus-eluting stent)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEB-BMS<br>Drug eluting balloon + Bare metal stent | Device: Drug eluting balloon + Bare metal stent<br>* PCI using Sequent Please and then Coroflex Blue<br>* Other names: Coroflex Blue (B.Braun, bare metal stent);|
| Active Comparator: Drug eluting stent<br>conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent) | Device: drug eluting stent (Zotarolimus-eluting stent)<br>* conventional PCI using Endeavor Integrity<br>* Other names: Zotarolimus-eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-segment late loss | angiographic in-segment late loss measure by QCA program | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stent thrombosis | any stent thrombosis | 9 month | 
| angiographic and procedure success | 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. | 9 month | 
| MACE | death, MI and TVF | 9 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting balloon, bare metal stent, drug eluting stent, coronary artery disease