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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEB-BMS | Experimental | Drug eluting balloon + Bare metal stent |
|
| Drug eluting stent | Active Comparator | conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting balloon + Bare metal stent | Device | PCI using Sequent Please and then Coroflex Blue |
|
| Measure | Description | Time Frame |
|---|---|---|
| in-segment late loss | angiographic in-segment late loss measure by QCA program | 9 month |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In-Ho Chae, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Universtiy Bundang Hospital | Seongnam | 463-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28480650 | Derived | Chae IH, Yoon CH, Park JJ, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ. Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial. J Korean Med Sci. 2017 Jun;32(6):933-941. doi: 10.3346/jkms.2017.32.6.933. | |
| 23394404 | Derived |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| D000789 | Angina, Unstable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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| drug eluting stent (Zotarolimus-eluting stent) | Device | conventional PCI using Endeavor Integrity |
|
|
| 9 month |
| MACE | death, MI and TVF | 9 month |
| Park SD, Yoon CH, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ, Chae IH. Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial. Trials. 2013 Feb 8;14:38. doi: 10.1186/1745-6215-14-38. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |