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| Name | Class |
|---|---|
| MedPass International | INDUSTRY |
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The propose of this study is to demonstrate, whenever using Drug Eluting Stent is not possible, the clinical security at 12 months, of the combinaison Bare Metal Stent plus Drug Eluting Balloon.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantera Lux Drug Eluting Balloon | Device | All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation. |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) at 12 months. | TLF is defined as a composite of cardiac death, any target vessel myocardial infarction (MI), urgent coronary artery bypass graft (CABG) and clinically driven target lesion revascularization (TLR). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure | 1 and 6 months | |
| Bleeding rate according to BARC definition | 1, 6 and 12 months | |
| Clinically driven target vessel revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jérôme Roncalli, Prof | CHU Toulouse, Hôpital Rangueil, TSA 50032, 31059 TOULOUSE Cedex 9 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Toulouse | Toulouse | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30927531 | Derived | Roncalli J, Godin M, Boughalem K, Shayne J, Piot C, Huret B, Belle L, Cayla G, Faurie B, Amor M, Karsenty B, Leclercq F. Paclitaxel Drug-Coated Balloon After Bare-Metal Stent Implantation, an Alternative Treatment to Drug-Eluting Stent in High Bleeding Risk Patients (The Panelux Trial). J Invasive Cardiol. 2019 Apr;31(4):94-100. doi: 10.25270/jic/18.00272. |
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| 1, 6 and 12 months |
| MACCE | Cardiac death, stroke, myocardial infarction (Q wave and non Q wave) and TVR by non planned angioplasty or bypass graft | 1, 6 and 12 months |
| All deaths | 1, 6 and 12 months |
| Myocardial Infarction (MI) (Q wave and non Q wave) | 1, 6 and 12 months |
| Definite incidence of stent thrombosis | 1, 6 and 12 months |
| Clinically driven target lesion revascularization | 1, 6 and 12 months |
| Target lesion failure for patients >/= 80 years | 1, 6 and 12 months |
| Bleeding rate according to BARC definition for patients >/= 80 years | 1, 6 and 12 months |
| Target lesion failure for kidney failure patients (clearance < 30 ml/ min) | 1, 6 and 12 months |
| Bleeding Rate according to BARC definition for kidney failure patients (clearance < 30 ml/ min) | 1, 6 and 12 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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