title: Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet-covered embolic prevention stent system.
abstract: OBJECTIVE
  Our aim was to determine (1) periprocedural and 30-day clinical safety and efficacy of the CGuard MicroNet-covered embolic prevention carotid stent system (MN-EPS) in routine use for unselected carotid stenosis (CS) patients undergoing CAS, as well as (2) feasibility of MN-EPS post-dilatation optimisation to minimise residual stenosis after CAS.
  
  
  RESULTS
  This was a non-industry-funded, prospective academic study in all-referrals-tracked symptomatic and asymptomatic CS. In asymptomatic lesions, intervention was mandated only in case of increased stroke risk CS features. There was independent neurologist evaluation before CAS, at 48 hours and 30 days. There was external source data verification, angiographic core lab, and statistical analysis. Over 11 months, 108 referrals were recommended by the NeuroVascular Team for revascularisation: 101 (51-86 years, 55 symptomatic, evolving stroke in nine) underwent 106 (100% MN-EPS use) neuroprotection device-assisted (46% proximal, 54% distal) CAS; CEA was performed in seven. MN-EPS device success was 99.1%. Angiographic diameter stenosis was reduced from 83±9% to 6.7±5% (p<0.001). No MN-EPS foreshortening/elongation occurred (30 mm long was 29.82±0.68 mm; 40 mm long was 39.89±0.59 mm). The periprocedural death/major stroke/MI rate was 0%. One event, with no change in NIHSS or modified Rankin Scale and no clinical sequel, was adjudicated by the clinical events committee as minor stroke (0.9%). By 30 days there were no new events (0%).
  
  
  CONCLUSIONS
  These increased risk consecutive patient data (1) indicate safety and efficacy of routine MN-EPS use in achieving endovascular reconstruction across all-comer CS lesion subsets, and (2) are consistent with MN-EPS protection against cerebral events extending throughout the stent healing period.
authors.affiliation: Jagiellonian University Department of Cardiac & Vascular Diseases, John Paul II Hospital, Krakow, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Musialek
authors.forename: Adam
authors.initials: A
authors.lastname: Mazurek
authors.forename: Mariusz
authors.initials: M
authors.lastname: Trystula
authors.forename: Anna
authors.initials: A
authors.lastname: Borratynska
authors.forename: Agata
authors.initials: A
authors.lastname: Lesniak-Sobelga
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Urbanczyk
authors.forename: R Pawel
authors.initials: RP
authors.lastname: Banys
authors.forename: Andrzej
authors.initials: A
authors.lastname: Brzychczy
authors.forename: Wojciech
authors.initials: W
authors.lastname: Zajdel
authors.forename: Lukasz
authors.initials: L
authors.lastname: Partyka
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Zmudka
authors.forename: Piotr
authors.initials: P
authors.lastname: Podolec
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000379:methods; D016893:Carotid Stenosis / Q000628:therapy*; D016894:Endarterectomy, Carotid / Q000379:methods; D005260:Female; D006801:Humans; D020766:Intracranial Embolism / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D020521:Stroke / Q000628:therapy*; D016896:Treatment Outcome