Safety and effectiveness of the INVATEC MO.MA® proximal cerebral protection device during carotid artery stenting: Results from the ARMOUR pivotal trial

Abstract

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.

Safety and efficacy of endovascular treatment for carotid artery stenoses using proximal protection systems: 30-day follow-up

“…Symptomatic patients were managed at least 5 days after neurologic event, preferentially on the 7 th -10 th day, depending on the findings of MRI of the brain and appearance of cerebral lesions revealed by this test; this was in line with recommendations coming from published studies [10,12].…”

“…Prevalence of ischaemic cerebral events during 30-day follow-up reported by randomised trials, with different types of DSP utilised, was at the level of 4% in asymptomatic patients, and even as high as 10% in symptomatic individuals [5][6][7][8][9]. By contrast, open-label studies when also a proximal protection has been applied (such a system was used in approximately 30% of procedures) reported much lower rates of adverse events: 0.9-2.4% of death or stroke [10][11][12][13]. There is a growing body of evidence supporting the use of PPS during CAS.…”

“…Regarding the Mo.Ma system, there are some already published studies [12,19,20]. In the randomized multicentre ARMOUR study, which evaluated a group of 222 patients (15% of them were symptomatic, 29% were older than 80 years; occlusion or stenosis of the contralateral artery constituted an exclusion criterion for the use of PPS) the composite complication rate (comprising: stroke, death and myocardial infarction) was 2.7%, and stroke rate during 30 days was 0.9% [12]. In the study published by Stabile et al the Mo.Ma system was used in 1,300 patients.…”

“…Most of published papers on CAS deal with distal protection systems (DPS) [5][6][7][8][9]. Still, it is believed that proximal protection systems (PPS) in terms of their safety and efficacy have potential advantage over distal ones, yet evidence of such superiority remains to be documented [10][11][12][13].…”

Carotid artery stenting: Single center experience and clinical consequences

“…Daha sonra sadece cerrahi açıdan yüksek riskli hastalarda KAS tedavisi tercih ediliyordu. KAS ile KAE tedavisini karşılaştıran ve KAS aleyhine olumsuz sonuçlanan bazı çalışmalara rağmen [12][13][14] daha sonra medikal tedavide, cihaz teknolojisinde ve girişimsel kardiyolojideki gelişmelere paralel olarak yapılan çalışmalarda KAS tedavisinde mortalite ve tekrarlayan iskemik inme riskinde belirgin gerileme (%7'lerden %2'lere) olduğu görülmüştür [15][16][17][18]. Bu cihazların kullanımı ile birlikte yapılan yakın zamanlı kapsamlı çalışmalarda KAS tedavisi uygulanan hastalarda klinik sonuçların KAE ile benzer olduğu tespit edilmiş [4,5].…”