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Saadi et al. Vessel Plus 2020;4:41 I http://dx.doi.org/10.20517/2574-1209.2020.54 Page 5 of 14
Device successfully deployed: 100% 7 days DW-MRI new ischemic lesions: 100% vs. 100% Median number of defects per patient: 8 (3-13) vs. 4 (2-8); P = 0.41 Lesion volume per lesion: 30 mm 3 (20- 50) vs. 50 mm 3 (30-70); P = 0.003 New foci of restricted diffusion: 57% vs. 67%; P = 0.7 Lesion size: 88 ± 60 mm 3 vs. 168 ± 217 mm 3 ; P = 0.27 Lesion volumes in the supply region of the middle cerebral artery: 33 ± 29 mm 3 vs. 76 ± 67 mm 3 ; P = 0.0
52 patients who underwent transfemoral TAVI with (n = 41) or without (n = 11) Embrella From July 2012 to April 2014, 30 patients randomized 1:1 to TAVI with (n = 14) or without EMBOL-X (n = 16) 20 patients submitted to TAVI with Emblok 3 centers in New Zealand 24 patients submitted to TAVI with Emboliner Estimated enrollment: randomized to TAVR with or without Sentinel 328 patients submitted to TAVI with or without Se
Periprocedural cerebral lesions assessed by DW-MRI Periprocedural cerebral lesions assessed by DW-MRI at baseline and within 7 days post-TAVI Primary endpoint: technical success and immediate nonrandomized, cerebral embolic burden after TAVI (number and volume of new brain lesions detected by DW-MRI at days 2 to 5 post-TAVI compared with baseline) Primary safety endpoint: 30-day MACCE incidence Technical performance: technical success (ability to
Prospective and nonrandomized trial Prospective, single-center, randomized- controlled trial Prospective, multicenter, first-in-man pilot study Prospective, non- randomised, multicentre, open-label study Prospective randomized trial Prospective randomized trial Prospective, observational, multi-center, intention-to- treat study days MACCE: major adverse cardiac and cerebrovascular events; DWI-MRI: diffusion-weigh
Embrella (CE Mark approval) EMBOL-X Emblok Emboliner Sentinel Sentinel ProtEmbo
Early clinical presented at TCT 2019 Recruiting NCT04149535 Recruiting NCT02895737 Recruitment completed, not published NCT03325283
2014 2015 2020 results
PROTAVI-C Pilot EMBOL-X trial Emblok Embolic study SafePass 2 Ongoing trials PROTECTED TAVR PROTECT TAVI PROTEMBO SF Trial
