La sperimentazione clinica con dispositivi medici in Italia:
stato dell’arte e prospettive
Dott. Paolo Rubino
Direttore Laboratorio di Cardiologia Invasiva
Clinica Montevergine, Mercogliano
Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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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
Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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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.
Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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“….Game Changer for Carotid Revascularization…”
White et al. JACC 2010
Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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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.
Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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Belgium
Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst
Aalst, Belgium, 9300
Recruiting
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
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
Kings College Hospital - NHS Trust
London, United Kingdom, SE5,9RS
Recruiting
ST. Thomas' Hospital - NHS Trust
London, United Kingdom, SE1 7EH
Recruiting
France
Germany
United Kingdom
Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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Proposta:
1. 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).
2. Una volta individuati, i centri devono essere
sottoposti a monitoraggio continuo da parte degli
organismi competenti
3. Tali centri devono avere una corsia preferenziale
(rapida) per l’accesso alla sperimentazione
Dott. Paolo Rubino – Responsabile Laboratorio di cardiologia Invasiva, Clinica Montevergine
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