La sperimentazione clinica con dispositivi medici in Italia: stato dell’arte e prospettive

1. La sperimentazione clinica con dispositivi medici in Italia: stato dell’arte e prospettive Dott. Paolo Rubino Direttore Laboratorio di Cardiologia Invasiva Clinica Montevergine, Mercogliano

2. Safety and effectiveness of the INVATEC MO.MA(R) proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial.Ansel GM, Hopkins LN, Jaff MR, Rubino P, Bacharach JM, Scheinert D, Myla S, Das T, Cremonesi A; The Investigators for the ARMOUR Pivotal Trial.Objective:The multicenter ARMOUR (ProximAl PRotection with the MO.MA Device DUring CaRotid Stenting) trial evaluated the 30-day safety and effectiveness of the MO.MA(R) Proximal Cerebral Protection Device (Invatec, Roncadelle, Italy) utilized to treat high surgical risk patients undergoing carotid artery stenting (CAS). Background: Distal embolic protection devices (EPD) have been traditionally utilized during CAS. The MO.MA device acts as a balloon occlusion "endovascular clamping" system to achieve cerebral protection prior to crossing the carotid stenosis.Methods:This prospective registry enrolled 262 subjects, 37 roll-in and 225 pivotal subjects evaluated with intention to treat (ITT) from September 2007 to February 2009. Subjects underwent CAS using the MO.MA device. The primary endpoint, myocardial infarction, stroke, or death through 30 days (30-day major adverse cardiac and cerebrovascular events [MACCE]) was compared to a performance goal of 13% derived from trials utilizing distal EPD.Results:For the ITT population, the mean age was 74.7 years with 66.7% of the cohort being male. Symptomatic patients comprised 15.1% and 28.9% were octogenarians. Device success was 98.2% and procedural success was 93.2%. The 30-day MACCE rate was 2.7% [95% CI (1.0-5.8%)] with a 30-day major stroke rate of 0.9%. No symptomatic patient suffered a stroke during this trial. Conclusions:The ARMOUR trial demonstrated that the MO.MA(R) Proximal Cerebral Protection Device is safe and effective for high surgical risk patients undergoing CAS. The absence of stroke in symptomatic patients is the lowest rate reported in any independently adjudicated prospective multicenter registry trial to date. (c) Catheter Cardiovasc Interv. 2010 Jan 25

3. Use of endovascular clamping as neuroprotection during carotid stenting in the presence of a critical ipsilateral stenosis of the external carotid artery. Stabile E, Sorropago G, Tesorio T, Salemme L, Ambrosini V, Cioppa A, Popusoi G, Nammas W, Biamino G, Rubino P. EuroIntervention. 2008 Mar;3(5):588-92 PRIAMUS--proximal flow blockage cerebral protectIon during carotid stenting: results from a multicenter Italian registry. Coppi G, Moratto R, Silingardi R, Rubino P, Sarropago G, Salemme L, Cremonesi A, Castriota F, Manetti R, Sacca S, Reimers B. J Cardiovasc Surg 2005 Jun;46(3):219-27 Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry. Reimers B, Sievert H, Schuler GC, Tübler T, Diederich K, Schmidt A, Rubino P, Mudra H, Dudek D, Coppi G, Schofer J, Cremonesi A, Haufe M, Resta M, Klauss V, Benassi A, Di Mario C, Favero L, Scheinert D, Salemme L, Biamino G. J Endovasc Ther. 2005 Apr;12(2):156-65.

4. “….Game Changer for Carotid Revascularization…” White et al. JACC 2010 4

8. PREVAIL EU Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe) This study is currently recruiting participants. A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrolment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

9. Belgium Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst Aalst, Belgium, 9300 Recruiting France Institut Hospitalier Jacques Cartier Massy, France, 91300 Recruiting Hospital Bichat Claude Bernard Paris, France, 75018 Recruiting CHU Hospital Charles Nicolle Rouen, France, 76031 Recruiting Clinique Pasteur Toulouse, France, 31076 Recruiting Germany Heart and Vessel Center Bad Bevensen, Germany, 29549 Suspended Hamburg University Cardiovascular Center Hamburg, Germany, 22527 Recruiting City Clinics Karlsruhe Karlsruhe, Germany, 76185 Recruiting Heart Center Leipzig Leipzig, Germany, 04829 Recruiting Schwabing Clinic Munich, Germany, 80804 Recruiting United Kingdom Kings College Hospital - NHS Trust London, United Kingdom, SE5,9RS Recruiting ST. Thomas' Hospital - NHS Trust London, United Kingdom, SE1 7EH Recruiting

10. Proposta: • Individuazione di centri idonei alla sperimentazione clinica sulla base dei volumi di attività, della qualità procedurale, della loro storia di centri sperimentatori e dell’attività scientifica (i.e. Impact Factor, Citation Index). • Una volta individuati, i centri devono essere sottoposti a monitoraggio continuo da parte degli organismi competenti • Tali centri devono avere una corsia preferenziale (rapida) per l’accesso alla sperimentazione