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The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB) | Experimental |
| |
| Drug Eluting Stent (DES) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coroflex Blue (BMS) followed by SeQuent Please (DEB) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) - target vessel failure (TVF) | consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (MACE) | defined as the composite of cardiovascular death, stroke, myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR), as well as the individual components of target vessel revascularization (TVR) and Major adverse cardiac events (MACE) and stent thrombosis | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paweł E. Buszman, MD, PhD | American Heart of Poland, Katowice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Upper Silesian Heart Center | Katowice | 40-635 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26224390 | Result | Zurakowski A, Buszman PP, Milewski KP, Janas A, Gorycki B, Kondys M, Gasior P, Michalak M, Boxberger M, Peppas A, Granada JF, Buszman PE. Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial. J Interv Cardiol. 2015 Aug;28(4):348-57. doi: 10.1111/joic.12210. |
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|
|
| Coroflex Please (DES) | Device |
|
|
|
| in-stent binary restenosis |
defined as >= 50 % diameter stenosis (% DS) |
| 9 months |
| Angiographic and clinical stent thrombosis | 30 days |
| Angiographic and clinical stent thrombosis | 6 months |
| Angiographic and clinical stent thrombosis | 9 months |
| Angiographic and clinical stent thrombosis | 1 year |
| Angiographic and clinical stent thrombosis | 2 years |
| Angiographic and clinical stent thrombosis | 3 years |
| In-stent and in-segment minimal luminal diameter (MLD) | 9 months |
| In-segment percent diameter stenosis (%DS) | 9 months |
| In-stent and in-segment late luminal loss | 9 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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