PROTOCOLES ET ETUDES

Transcription

1 PROTOCOLES ET ETUDES

2 ETUDE MUST : Janvier à Aout 1995 Protocole évaluant l efficacité de la ticlopidine comme traitement associé à la pose d une endoprothèse coronaire Johnson&Johnson Principal investigateur : DR M.C Morice Co-investigateurs : Drs Louvard, Lefevre, Dumas ETUDE PAMI-3 Stent Pilot :Début Juillet 1995 Etude pilote sur la pose d un stent vasculaire PAMI-3 (prothèses endocoronaires de première intention) chez les patients atteints d infarctus du myocarde en phase aigue Principaux Investigateurs : DR STONE (USA) DR MORICE (EUROPE) Co-investigateurs : Drs Louvard, Lefevre, Dumas, Karrillon ETUDE BENESTENT II : Juillet 1995 à Mars 1996 Etude comparative entre l angioplastie par ballonnet et l angioplastie avec implantation d un stent Palmaz Schatz hépariné dans le cas de sténose de novo chez des patients en angor stable ou instable Principal Investigateur : PR SERRUYS Investigateur en France: DR MORICE Co-investigateurs : Drs Louvard, Lefevre, Dumas, Karrillon ETUDE EASI : Janvier 1995 à Mars 1996 Etude du comportement de la prothèse CORDIS appliquée à des fins thérapeutiques dans les cas d angine de poitrine Co-investigateurs : Drs Morice, Louvard, Lefevre, Dumas, Karrillon

3 ETUDE CORSICA : Début 1995 Chronic occlusion revascularisation with stent implantation versus coronary angioplasty Principal Investigateur : Dr GUERIN Dr CHEVALIER Participant : Dr MORICE Co-investigateurs : Drs Louvard, Lefevre, Dumas, Karrillon ETUDE OPTIMAL AVE STENT DELIVERY PRESSURE PROTOCOL : Début 1996 Protocole de déploiement des stents AVE par échographie intracoronaire Principal Investigateur: Dr. Morice Co-investigateurs : Drs Louvard, Lefevre, Dumas, Karrillon ETUDE FINESS : Début 1996 Evaluation des stents NIR mm. Principaux Investigateurs : Dr ALMAGOR (ISRAEL) Dr LEON (USA) Investigateur en France Co-investigateurs : Dr MORICE Drs Louvard, Lefevre, Dumas, Karrillon ETUDE WEST II: Janvier 1996 Etude évaluant la qualité de déploiement des stents ACS MULTI-LINK en cours d angioplastie, par échographie endocoronaire. Principal Investigateur : Dr Morice Co-investigateurs : Drs Louvard, Lefevre, Dumas, Karrillon

4 ETUDE PAMI HEPARIN COATED STENT PILOT TRIAL : Avril 1996 Etude pilote sur la pose de première intention d une prothèse endocoronaire héparinée chez des patients atteints d infarctus du myocarde en phase aigue. Principal Investigateur Européen :Dr MORICE Co-investigateurs : Drs Louvard, Lefevre, Dumas, Karrillon ETUDE OPTICUS (début septembre Mars 1998) Principal Investigateur : DR M.C MORICE ETUDE ERASER Reopro en prévention de la resténose Principal Investigateur: Dr Lefevre Co-investigateurs : Drs Louvard, Morice, Dumas, Karrillon ETUDE ARTS (debut octobre 1996) Comparaison entre la chirurgie cardiaque et de l angioplastie avec implantation de prothèse endocoronaire. Principal Investigateur : ICPS. Dr Morice, Dr Donzeau Gouge Co-investigateurs Drs Louvard, Lefevre, Dumas, Karrillon ETUDE TRAPIST 1996 Principal Investigateur : Dr Morice Co-investigateurs : Drs Louvard, Lefevre, Dumas, Karrillon

5 ETUDE FINESS II 1996 Principal Investigateur : Dr. M.C. Morice Co-investigateurs: Drs Louvard, Lefevre, Dumas, Karrillon ETUDE EXACTO (en attente) Etude de la désobstruction coronaire par guide laser Principal Investigateur : Dr. Karrillon Co-investigateurs : Drs Louvard, Lefevre, Dumas, Morice ETUDE LARS (en attente) Etude du traitement de la resténose intra-stent par cathéter laser Principal Investigateur: Dr. Karrillon Co-investigateurs: Drs Louvard, Lefevre, Dumas, Morice ETUDE Trois troncs, trois stents Investigateur principal : Marie-Claude Morice ETUDE FAST Fibrinolysis for AMI followed by stenting and Techstar Investigateur principal: Dr. M.C. Morice

6 ADMIRAL ( ) Abciximab before direct angioplasty and stenting in myocardial infarction regarding acute and long terms follow-up Investigateur principal : Marie-Claude Morice EXCITE (Octobre 1997-avril 1998) Efficacy and safety of Xemilofiban Hydrochloride (SC A). Administration to patients undergoing coronary angioplasty and stent placement. Investigateur principal : Marie-Claude Morice BIFURCATIONS- JOSTENT - BESTENT (Septembre 1997) Investigateur principal : Thierry Lefèvre BESMART (1997) Investigateur principal : Thierry Lefèvre JOSTENT GRAFT (Octobre ) Investigateur principal : Marie-Claude Morice TECHSTAR (Février Investigateur principal : Jean-François Piéchaud ANGIOSEAL ( ) Investigateur principal : Thierry Lefèvre ADVANCE (1998- Additional value of NIR stents for treatment of long coronary lesions Randomized study of long stents versus balloons

7 Investigateur principal : Christophe Loubeyre SMILE (1998 Stenting with Multi-link in long coronary lesions Investigateur principal : Yves Louvard CLASSICS ( ) Clopidogrel Aspirin Stent International Co-operative Study. Investigateurs : Marie-Claude Morice-Thierry Lefèvre

8 PRESTO (1999- Prevention of restenosis with tranilast and its outcomes. A placebo-controlled trial Yves Louvard ESCAMI (1999- Evaluation of the safety and the cardioprotrective effects of EMD given as adjunctive therapy to reperfusion in patients with acute myocardial infarction. A randomized trial Investigators: Thierry Lefèvre, Marie-Claude Morice MAGIC (1999- BIOTRONIK (1999- Evaluation of the Biotronik endoprosthesis in small coronary vessels Protocoles ICPS. - Resténose Intra-stent Investigateurs: Thierry Lefèvre - - Reverse stand-by (stenting chez les patients présentant une ischémie aiguë après pontage) Investigateurs: Thierry Lefèvre - - Stenting des troncs communs Investigateurs: Thierry Lefèvre - - Stenting de première intention dans l IDM aigu Investigateurs: Christophe Loubeyre - - IDM Investigateurs: Christophe Loubeyre - - 5F versus 6F Investigateurs: Thierry Lefèvre/Yves Louvard

9 VELOCITY Use of Velocity stents in coronary bifurcations (Cordis) Investigators: Thierry Lefèvre/Yves Louvard Cordis NUGGET Nir Royal (Boston Scientific) Investigator: Marie-Claude Morice Boston Scientific JOSTENT RECOVER Implantation of covered stents Investigateurs: Marie-Claude Morice Jomed NIR SIDE Implantation of NIR SIDE stents in coronary bifurcations Investigateurs: Marie-Claude Morice Boston Scientific RESCUT Restenotic cutting balloon evaluation Investigateurs: Marie-Claude Morice Thierry Lefèvre IVT RAVEL A randomized study with the Sirolimus coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions. Investigateur: Marie-Claude Morice Cordis

10 2001 EUROSPAH European Sonotherapy Prevention of Arterial Hyperplasia Pharmasonics BIFURCATION SIROLIMUS An Evaluation of the Sirolimus-Coated BX Velocity Balloon-Expandable Stent in the Treatment of Patients with Bifurcation Lesions. Investigator: Marie-Claude Morice Cordis SPLASH Sonotherapy Prevention of Late Arterial in-stent Hyperplasia Pharmasonics DISCOVER Distal Protection Combined with Velocity in Coronary Arteries SVBG Registry Cordis ACTION Actynomicyn-coated Tetra D Stent Improves Outcomes by Reducing Neo-Intimal Hyperplasia Investigator: Marie-Claude Morice Guidant BRILLIANT Batismastat BB 94 Anti-restenosis Trial Utilizing the Biodivysio Local Drug Delivery PC Stent. Biocompatibles X- AMINEST X-sizer in AMI patients for negligible embolization and optimal ST resolution Endicor MAVERIC Evaluation of the Medtronic/AVE Self Expanding Carotid Stent System with Distal Protection in the Treatment of Carotid Stenosis. Medtronic DIPLOMAT Distal protection combined with PTCA in acute myocardial infarction patients Cordis

11 HELI STENT Evaluation clinique de l endoprothèse coronaire Helistent Tino Hexacath Protocoles ICPS Registre Bifurcations Registre Troncs communs Registre IDM Registre angioplastie des artères rénales

12 RESUS 1 Evaluation of the Express stent Thierry Lefèvre Boston Scientific NIR TOP TRIAL Thierry Lefèvre Medinol DELIVER Prospective non-randomized multicenter evaluation of the ACHIEVE Paclitaxel eluting coronary stent system in the treatment of lesions with high risk of revascularization due to restenosis Investigator: Marie-Claude Morice Guidant FRONTIER A multicenter prospective, non randomized registry for the purpose of evaluating the safety and performance of the Multi-link Frontier coronary stent system for the treatment of patients with de novo or restenotic bifurcation coronary artery lesions. Thierry Lefèvre Guidant TAXUS VI A randomized double blind study to assess paclitaxel-eluting stents in the treatment of longer lesions Marie-Claude Morice Boston Scientific TULIP Registry Evaluation of the Multi-link Pent coronary stent system for the treatment of coronary bifurcation lesions. Thierry Lefèvre Sponsor Guidant SIROCCO In-stent intimal proliferation and carbofilm coating Thierry Lefèvre Sorin Biomedica CAPTIVE Cardio-shield application protects during transluminal intervention of vein graft by reducing emboli Thierry Lefèvre MedNova BRIDGE Registry

13 Evaluation of the Sirolimus-eluting stent in diabetic patients Marie-Claude Morice Cordis ASTEROID A Study to evaluate the effect of rosuvastatin on intravascular ultra-sound derived coronary atheroma burden Marie Claude Morice Astra-Zeneca ARTS II study Arterial Revascularization Therapies Study part II of the sirolimus-eluting Bx VELOCITY balloon expandable stent in the treatment of patients with de novo coronary artery lesions. Marie-Claude Morice CORDIS MILESTONE II Scimed Boston Scientific Online TAXUS Stent European Registry Thierry Lefèvre Boston Scientific SCEPTER Study of Controlled Elution of Paclitaxel for the Elimination of Restenosis Pierre Dumas Conor Medisystem ENDEAVOR II A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic AVE ABT-578 Eluting Driver Coronary Stent in de novo Native Coronary Artery Lesions. Yves Louvard Medtronic REALITY A Prospective Randomized Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems. Marie-Claude Morice Cordis

14 DESIRE Double vs Single Balloon Stent Delivery Systems for Bifurcation Lesions : A Comparative Evaluation Thierry Lefèvre Invatec BIFURCATION REGISTRY Use of Sirolimus-Eluting Stents in Coronary Bifurcation Lesions Thierry Lefèvre Cordis Protocoles ICPS OCTO-PLUS (radial approach in octogenarians) Yves Louvard ESTERNAL Registry (renal stenting) Marie-Claude Morice AMI registry

15 2004 PACIFIQUE Post Coronary Angioplasty and PCI registry Thierry Lefèvre Novartis TYPHOON A multicenter, randomized, single-blind Trial to assess the use of the cypher tm acute myocardial infarction treated with balloon angioplasty stent in Marie-Claude Morice Cordis JUPITER II Treatment of Restenosis of Coronary Lesions with Tacrolimus-eluting Sorin Janus Carbostent in Direct Stenting Marie-Claude Morice Sorin Biomedica CARESS IN AMI Combined Abciximab Reteplase Stent Study in Acute Myocardial Infarction Marie-Claude Morice Gise SHOCK II A Randomized Double-Blind Placebo-Controlled, Dose-Ranging Study of Nitric Oxide Synthase Inhibition with NG-Monomethyl-L-Arginine (L-NMMA) in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction : Preliminary Evaluation of Safety, Efficacy and Biological Activity. Thierry Lefèvre Arginox ASSENT IV A Phase IIIb-IV, Randomized Open Label Trial Evaluation the Efficacy and Safety of Tenecteplase Together With Unfractioned Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction Marie-Claude Morice Boehringer

16 STEEPLE Safety and Efficacy of Enoxaparin in PCI patients, an international randomized Evaluation Thierry Lefèvre Aventis FLAME Use of the EZ Filter Wire in the treatment of AMI. A prospective, multicenter, randomized study Thierry Lefèvre Boston Scientific FX MINIRAIL Impact of Fx-minirail sidebranch predilatation. A randomized evaluation using QCA and IVUS in 30 selected cases OPTIMAL Post thrombolysis Assessment of AMI patients. A prospective, observational study Investigators : Thierry Lefèvre, Philippe Garot Boerhinger

17 2005 ACUITY Acute catheterization and urgent intervention thrombotic strategy. A randomized, international, multicenter study. Yves Louvard SYNTAX Synergy between PCI with TAXUS and Cardiac Surgery. A multicenter, randomized clinical trial comparing TAXUS PCI to CABG in patients amenable for revascularization treatment of 3-vessel disease, left main disease or left main in conjunction with one, two or three vessel disease. Marie-Claude Morice Boston Scientific JANUS Evalutation of the Janus Carbostent Tacrolimus eluting stent. Prospective, non-randomised, multicenter registry Marie-Claude Morice Sorin TAROT Rotablator registry Thierry Lefèvre FRIEND Assessment of TAXUS eluting stent implantation in unprotected left main coronary arteries. A multicenter prospective study Thierry Lefèvre Boston Scientific AMIHOT II Acute Myocardial Infarction with Hyperoxemic Therapy II A prospective multicenter randomized study of aqueous oxygen therapy for 90 minutes in anterior acute myocardial infarction patients with successful PCI/Stenting presenting within < six hours from time of symptom onset until time of reperfusion

18 Investigator: Thierry Lefèvre Therox SEPIA A multinational, randomized, double-blind, double dummy, exploratory, parallel group, dose-ranging phase II Study to Evaluate the Pharmacodynamics, the safety and tolerability and the pharmacokinetics of several Intravenous regimens of the factor Xa inhibitor otamixaban (XRP0673), in comparison to intravenous unfractionned heparin, in subjects undergoing non-urgent Percutaneous Coronary Intervention Investigator: Thierry Lefèvre Sanofi/Aventis NOBORI I A prospective, randomized multicenter comparison of Nobori and Taxus drug-eluting stents systems Investigators : Marie-Claude Morice, Philippe Garot Terumo STRADIVARIUS Strategy to reduce atherosclerosis development involving administration of Rimonabant. The intravascular ultrasound study. A multicenter, doubleblind, placebo-controlled, randomized study Investigator: Philippe Garot SANOFI/AVENTIS

19 FAR French registry of PCI in the real world Investigators: Thierry Lefèvre Philippe Garot Coordination: GACI CUSTOM II Xtent Custom Single (CS 36) and Multiple (CM 60) drug eluting stent (DES) Catheter System Feasibility Trial Investigator: Marie-Claude Morice X TENT TRITON A comparison of CS-747 and Clopidogrel in Acute Coronary Syndrome Subjects who are Undergo Percutaneous Coronary Intervention / TIMI 38 A randomised, double-blind controlled multicenter study Investigators : Marie-Claude Morice Philippe Garot Lilly EXPORT A randomized study comparing the efficacy and safety of thromboaspiration followed by PCI with PCI alone in the treatment of acute ST-elevation myocardial infarction (STEMI) < 12 hours in patients with initial TIMI Flow < 3. Medtronic OLYMPIA A registry of recipients of the Taxus Liberté stent Investigator: Marie-Claude Morice Boston Scientific

20 GENOUS A pilot study to evaluate the Genous Bio-engineered R stent TM in patients treated with reduced antiplatelet therapy. A spontaneous multicenter trial. Marie-Claude Morice CRISTAL Comparison of the performance of the CYPHER Select Sirolimus-eluting stent vs. balloon angioplasty in the treatment of in-stent restenosis Investigators: Thierry Lefèvre - Philippe Garot Cordis REVIVE Registry of Endo-Vascular Implantation of valves in Europe Edwards PARADIGM Iica A study evaluating the PFX system: PFO closure system in patients with a history of stroke, transient ischemic accident or embolism Investigator: Jean-François Piéchaud CIERRA GENESIS A randomized multicenter study of the Picrolimus-eluting and Picrolimus-Paclitaxel eluting coronary stent systemes in patients with de novo lesions of the native coronary artery Principal Investigator: Marie-Claude Morice CONOR Medsystems TRYTON FIM Study A multicenter prospective single arm study on the feasibility and safety of the Tryton side branch stent used in conjunction with the CYPHER sirolimus-eluting stent in the treatment of de novo native coronary bifurcated lesions Investigator: Marie-Claude Morice, Thierry Lefèvre, Yves Louvard, Alice Ohanessian Tryton Medical CUSTOM III XTENT Custom Nx 60 drug-eluting stent catheter system trial. A prospective registry

21 Investigator: Marie-Claude Morice X Tent LEADERS Limus eluted from a durable versus erodable stent coating A randomized trial Investigators: Marie-Claude Morice Biosensors RASCAL Renal Artery Stenting and Cardiac Linkage Multi-center Registry Investigator: Marie-Claude Morice Boston Scientific International OBSERVE Management and one-year outcome of patients admitted to a cardiology department receiving a combination of clopidogrel and aspirin French multicenter, prospective, observational study Sanofi Aventis INSIGHT Insights into the mechanism of percutaneous revascularization of coronary bifurcation disease in the drug-eluting stent era. An Angiographic and Intravascular Ultrasound Study Trial Coordination: University of Florida Health E- SELECT Cypher stent post marketing surveillance study Multicenter registry Philippe Garot Cordis TITAN 2 Follow-up study of the TITAN trial patients French registry

22 Phlippe Garot (study requested by the French Health Authorities) SPIRIT WOMAN A clinical evaluation of the Xience V everolimus eluting stent system in the treatment of women with de novo coronary artery lesions- A multicenter, single-arm, prospective study. Investigator: Marie-Claude Morice Abbott Cardiovascular Systems. PETAL TAXUS Petal Bifurcation Stent First Human Use: A prospective, single-arm, multicenter, two-phase feasibility study to assess the TAXUS Petal Paclitaxel-eluting bifurcation coronary stent system for the treatment of de novo atherosclerotic bifurcation lesions. Boston Scientific PARTNER: Non randomized, prospective, European multicenter pivot trial on the implantation of the Cribier Edwards bio-prosthesis in the treatment of severe aortic stenosis, via the retrograde arterial approach or the trans-apical approach. Edwards Thierry Lefèvre e- HEALING Genous bio-engineered R stent. Post Marketing Registry. A multicenter, worldwide, prospective registry. Investigator: Marie-Claude Morice OrbusNeich Medical

23 PLATO A Study of PLATelet inhibition and Patient Outcomes. A randomized double-blind multicenter study Thierry Lefèvre Philippe Garot ASTRAZENECA

24 OPEN 1 First-in-Man Study of the Stentys coronary bifurcation stent system for the percutaneous treatment of de novo lesions in native bifurcated coronary arteries STENTYS SAS RES- ELUTION A randomized, multi-center, single-blind comparison of the Conor Cobalt Chromium reservoir based stent with sirolimus elution versus the TAXUS Liberté paclitaxeleluting coronary stent system in de novo native coronary artery lesions. Investigator: MC. Morice Conor Medsystems/Cordis PROENCY A comparative registry of the Promus, Endeavor and Cypher drug-eluting stent coronary systems for the treatment of coronary lesions Investigator: Bernard Chevalier Boston Scientific RESOLUTE III A randomized comparison of a zotarolimus-eluting stent with an Everolimus-eluting stent for percutaneous coronary intervention Investigator: Philippe Garot Medtronic E- BIOMATRIX E-registry of the use of the Biomatrix stent (Biolimus stent) in percutaneous coronary intervention. Biosensors COREVALVE International ReValving Registry: Percutaneous aortiv valve replacement (PAVR) with the CoreValve ReValving System CoreValve ECLS Randomized, national, multicenter comparison of two strategies for the treatment of AMI patients with cardiogenic shock: Conventional treatment versus conventional treatment with extra corporeal life support.

25 CHU de Caen SOURCE Edwards SAPIEN Aortic Bioprosthesis European Outcome Registry Edwards LIBERTY ONE An International multicenter prospective single arm study to investigate procedural clinical and angiographic outcomes using the Taxus Liberté Stent, with improved side branch access, following the provisional side branch T-stenting approach in patients with bifurcation lesions. BSCI ITALIC Non-inferiority national multicenter study of aspirin alone compared with dual antiplatelet therapy combining aspirin and clopidogrel for 6 months after implantation of a Xience stent. Investigator: Thomas Hovasse Philippe Garot Société Française de Cardiologie STREAM Comparison of the efficacy and safety of a strategy of pre-hospital fibrinolytic treatment with tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterization within 6-24 hours or rescue coronary intervention versus a strategy of standard primary PCI in patients with acute myocardial infarction within 3 hours of onset of symptoms. Investigator: Marie-Claude Morice Philippe Garot Boehringer PLATINUM A prospective randomized multicenter trial to assess an everolimus eluting coronary stent system (Promus Element ) for the treatment of up to 2 de novo coronary artery lesions. Investigator: Thomas Hovasse Boston Scientific COHEREX A multi-center study to determine the response to closure of patent foramen

26 ovale (PFO) with the Coherex FlatStentTM EF PFO Closure System in patients diagnosed with PFO and significant oxygen desaturation in obstructive sleep apnea (OSA). Investigator: Jean-François Piéchaud Coherex Medical BLAST Bifurcation Lesion Analysis and Stenting Global, multicenter, prospective, two-arm randomized study Volcano ABSORB A clinical evaluation of the BVS everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions. Investigator: Bernard Chevalier ABBOTT FAR XIENCE V Evaluation of PCI with implantation of a Xience V stent within LPPR Indications in patients followed up for two years Investigator: Thomas Hovasse Philippe Garot GACI TRACER A Multicenter, randomized, double blind placebo-controlled study to evaluate the safety and efficacy of SCH in addition to standard of care in subjects with acute coronary syndrome: Thrombin receptor antagonist for clinical event reduction in acute coronary syndrome (TRACER) Schering-Plough SATURN IVUS evaluation of the effect of rosuvastatine on intra-coronary atheroma deposits. Multicenter, double blind, Phase IIIb trial comparing by IVUS evaluation the effect of rosuvastatine (40mg) with atorvastatine (80 mg) in patients with atherosclerosis. Investigator: Philippe Garot AstraZeneca PREVAIL EUROPE Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial

27 Edwards BVAP French Registry of Percutaneous Valve Implantation (CoreValve Revalving System or Edwards-Sapien )

28 ABSORB EXTEND A Continuation in the clinical evaluation of the BVS Everolimus eluting coronary stent system in the treatment of subjects with de novo native coronary artery lesions. Investigator: Bernard Chevalier ABBOTT CRISP AMI A Multi-Center Randomized Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size pre-pci for Acute Myorcardial Infarction DATASCOPE FRANCE 2 A Multicenter, Prospective, Open, Non-randomized French Registry of transcatheter Implantation of two types of Valvular Bioprotheses (Sapien, Edwards Lifescience, Irvine, California, Usa; CoreValve, Medtronic, USA) in Patients With Severe, Degenerative Aortic Stenosis. GIANT French Study. Genotyping of Patients with Acute Myocardial Infarction in order to adjust and normalize their Thienopyridine Treatment Investigator: Bernard Chevalier Biotronik REVALV Multicenter, Prospective, Comparative, Open, Non-randomized French Study. Medico- Economic Assessment of non surgical pulmonary valve replacement in the treatment of right ventricular outflow tract lesions. Investigator: Jean-François Piéchaud Assistance Publique Hôpitaux de Paris LEMAX Observational Trial Assessing the Outcome of Patient with Left Main Coronary Artery Disease Treated With Implantation of a Xience V Drug-Eluting Stent Investigator: Marie-Claude Morice CERC XERES

29 French Clinical Study Assessing the 2-Year Clinical Outcome of Patients Treated With an Everolimus-Eluting Stent (XIENCE V) for in-stent (Bare Metal Stent) Restenosis ABBOTT SPIDER Spider TM PFO Closure System Approval Study A safety, performance, non-randomized, multi-center, open label, non-comparative, prospective interventional clinical investigation in subjects who are candidates for the implantation of a PFO Closure Device Investigator: Jean-François Piéchaud Lifetech Scientific APPOSITION III A post-market study to assess the Stentys self-expanding coronary stent in acute myocardial infarction in real life Stentys EUROMAX European Ambulance ACS angiox trial, a prospective, open and non competitive study The Medicines Company COREVALVE ADVANCE International post-marketing study Prospective, multi-center study in patients with severe aortic valve stenosis requiring the implantion of a Corevalve Investigator: Bernard Chevalier Medtronic

30 DESSOLVE II Randomised multicenter prospective single blind trial comparing the MISTENT stent with the ENDEAVOR stent in the treatment of patients with de novo lesions in native coronary arteries Investigator: Marie-Claude Morice Micell Technologies OPEN I First in man clinical feasibility study on the Stentys coronary bifurcation stent in the treatment of de novo lesions located in a bifurcation of native coronary arteries. Stentys BIOFLOW II Assessment of the safety and clinical efficacy of the Orsiro drug-eluting stent in the treatment of patients with a single de novo coronary artery lesion. An international, multicenter, prospective, randomized, non inferiority, comparative study. BIOTRONIK TRYTON IDE Single blind, prospective, randomized, controlled study assessing the safety and efficacy of the Tryton Side Branch Stent combined with a DES compared with PCI and implantation of a DES in the side branch in the treatment of bifurcation de novo lesions of native coronary arteries. Tryton Medical WAVE CREST COHEREX WaveCrest left atrial appendage occlusion study A multi-center study to evaluate the safety and efficacy of the Coherex WaveCrest left atrial appendage occlusion system Investigator: Jean-François Piéchaud Coherex Medical

31 PREVAIL EU Transfemoral placement of aortic balloon expandable transcatheter valves trial A single arm, prospective, multicenter, non randomized confirmatory clinical trial evaluating the Edwards Sapien XT transcatheter heart valve Edwards LifeSciences e- NOBORI FRANCE Observational Multicenter, single arm non randomized prospective study assessing the safety and efficacy of the Nobori drug-eluting stent Investigators: Thomas Hovasse, Philippe Garot Terumo PLATINUM- PLUS A Prospective, Randomized, Multi-center Trial to Assess the Everolimus-Eluting Coronary Stent System (PROMUS Element) for Coronary Revascularization in a Population of Unrestricted Patients and determine the safety and effectiveness of Boston Scientific s Everolimus-eluting coronary stent system (PROMUS Element ) for coronary revascularization in an unrestricted population compared to the Xience Prime control. Investigators: Thomas Hovasse, Thierry Unterseeh CERC

32 DIRECT FLOW IP 010 Evaluation of a percutaneous aortic valve system, the 18 F Direct Flow, in the treatment of patients presenting with severe aortic stenosis Thierry Lefèvre Direct Flow Medical, Inc. EXCEL Assessment of the efficacy of the XIENCE PRIMETM ou Xience V drug-eluting stent compared to coronary artery bypass grafting in the revascularization of the left main coronary artery Investigators: Thierry Lefèvre, Marie-Claude Morice Abbott E- BIOMATRIX FRANCE Observational, non-interventional multicenter surveillance post market study of the use of BioMatrix TM (Biolimus A9 TM stent) in France Investigator: Thierry Lefèvre Biosensor

33 2012 MASTER TRIAL (MGuard for Acute ST Elevation Reperfusion The MASTER Trial) Objective: to demonstrate the superiority of the MGuard TM stent over commerciallyapproved bare-metal (BMS) / drug-eluting (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST elevation myocardial infacrtion (STEMI) Investigator: Thierry Lefèvre INSPIRE RESPOND Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D Investigator: Jérôme HORVILLEUR SORIN ATLANTIC Administration of Ticagrelor in the Cath Lab or in the Ambulance for New st elevation myocardial Infarction to open Coronary artery. Investigator Massy : Investigator Quincy: Thomas HOVASSE Philippe GAROT AstraZeneca DEBSIDE Multicentre, non randomized, prospective trial evaluation a paclitaxel-eluting balloon (DANUBIO) in the treatment of de novo bifurcated lesions in 2.0 mm and 3.0 mm side branches. Investigator Massy: Thierry Lefèvre Minvasys