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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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The purpose of this study is to demonstrate that a BioFreedom⢠Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BioFreedom⢠Drug Coated Stent (DCS) | Experimental | BA9 drug coated stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 mm and 4.0 mm. |
|
| Gazelle⢠Bare Metal Coronary Stent (BMS) | Active Comparator | GAZELLE⢠bare metal stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 and 4.0 mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofreedom⢠Drug Coated Stent (DCS) | Device | Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite Safety Endpoint | Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year | one year |
| Primary Efficacy Endpoint | The incidence of clinically driven target lesion revascularization | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Urban, MD | HƓpital de la Tour | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HƓpital de la Tour | Meyrin | 1217 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38626080 | Derived | Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16. | |
| 29951803 |
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|
| Gazelle⢠Bare Metal Coronary Stent (BMS) | Device | Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT |
|
| Derived |
| Richardt G, Maillard L, Nazzaro MS, Abdel-Wahab M, Carrie D, Iniguez A, Garot P, Abdellaoui M, Morice MC, Foley D, Copt S, Stoll HP, Urban P. Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial. Clin Res Cardiol. 2019 Jan;108(1):31-38. doi: 10.1007/s00392-018-1308-1. Epub 2018 Jun 27. |
| 28838473 | Derived | Carrie D, Menown I, Oldroyd K, Copt S, Talwar S, Maillard L, Morice MC, Teik LS, Lang I, Urban P. Safety and Efficacy of Polymer-Free Biolimus A9-Coated Versus Bare-Metal Stents in Orally Anticoagulated Patients: 2-Year Results of the LEADERS FREE Oral Anticoagulation Substudy. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1633-1642. doi: 10.1016/j.jcin.2017.05.033. |
| 27806919 | Derived | Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, Carrie D, Naber C, Iniguez A, Talwar S, Menown IBA, Christiansen EH, Gregson J, Copt S, Hovasse T, Lurz P, Maillard L, Krackhardt F, Ong P, Byrne J, Redwood S, Windhovel U, Greene S, Stoll HP, Urban P; LEADERS FREE Investigators. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. J Am Coll Cardiol. 2017 Jan 17;69(2):162-171. doi: 10.1016/j.jacc.2016.10.009. Epub 2016 Oct 30. |
| 26466021 | Derived | Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14. |
| 23622906 | Derived | Urban P, Abizaid A, Chevalier B, Greene S, Meredith I, Morice MC, Pocock S. Rationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy. Am Heart J. 2013 May;165(5):704-9. doi: 10.1016/j.ahj.2013.01.008. Epub 2013 Feb 19. |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D009203 | Myocardial Infarction |
| D006470 | Hemorrhage |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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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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