Clinical Trial Services

The Buffalo Neuroimaging Analysis Center (BNAC) is a dedicated research center that has expertise investigating imaging endpoints for cerebral embolic protection devices for transcatheter aortic valve replacement (TAVR) and other cardiovascular procedures. Our team uses both qualitative and quantitative analysis of diffusion magnetic resonance imaging (MRI), computerized tomography (CT), and magnetic resonance and digital subtraction angiography for clinical research. BNAC has served as Clinical Core Lab for a number of pivotal clinical trials related to cerebral protection devices. 

These devices protect the brain from embolic debris dislodged during the intervention. Using diffusion MRI, BNAC is able to detect and quantify new ischemic lesions as an endpoint in regulatory trials. Additionally, BNAC has been actively leading the improvement of these imaging endpoints to better evaluate the efficacy of these devices. In addition to being a key member of the NeuroARC consortium, BNAC has worked extensively to study the relationship between specific lesion volumes and clinical disability worsening, and was able to demonstrate that a more sophisticated analysis technique called supra-threshold ischemic lesion (SCIL) volume can better quantify clinically meaningful lesion volumes. Additionally, this measure can reveal substantial evidence of device efficacy that can otherwise be hidden by the presence of many small, temporary lesions. This work was recently presented at the annual TCT 2020 congress

For more information about imaging endpoints, click here.

FEATURED RECENT CLINICAL TAVR TRIALS 

  • Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, Horwitz P, Makkar R, Stoler R, Forrest J, Messe S, Dickerman S, Brennan J, Zivadinov R, Dwyer MG, Lansky AJ, Investigators RIT (2021) Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement: REFLECT II. JACC Cardiovasc Interv 14:515-527 [Open article]

  • Lansky AJ, Messe SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A (2017) Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. J Am Coll Cardiol 69:679-691 [Open article]

  • Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A, Investigators ST (2017) Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 69:367-377 [Open article]

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Part of BNAC’s mission is to help share our tools and experience with our colleagues and other industry partners. If you need help with managing a medical imaging trial related to cerebral embolic protection, please reach out to discuss how we can assist. Our group brings decades of experience and expertise to every collaborative study and service partnership.

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