Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol vShield device for the treatment of IVUS and OCT-derived thin cap fibroatheromas (TCFAs) in native coronary arteries: report of the pilot study vShield Evaluated at Cardiac hospital in Rotterdam for Investigation and Treatment of TCFA (SECRITT)

Joanna Wykrzykowska, Roberto Diletti, JL Gutierrez-Chico, Robert Jan van Geuns, Wim Giessen, S Ramcharitar, Eric Duckers, Carl Schultz, Pim Feijter, M van der Ent, Evelyn Regar, Peter de Jaegere, Hector Garcia Garcia, R Pawar, N Gonzalo, Jurgen Ligthart, J de Schepper, N (Nico) van den Berg, K Milewski, JF GranadaPWJC (Patrick) Serruys

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Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and optical coherence tomography-derived thin cap fibroatheroma (TCFA), with a dedicated nitinol self-expanding vShield device. Methods and results: After screening with angiography, fractional flow reserve (FFR), intravascular ultrasound virtual histology (IVUS-VH) and optical coherence tomography (OCT), 23 patients met enrolment criteria (presence of non-obstructive VH-derived TCFA lesion with thin cap on OCT) and were randomised to vShield (n=13) versus medical therapy (n=10). In the shielded group, baseline percent diameter stenosis was 33.1+/-13.5%, FFR was 0.93+/-0.06. At six-month follow-up in shielded patients pe Conclusions: High risk plaque passivation and sealing with a vShield self-expanding nitinol device appears feasible and safe. A long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.
Original languageUndefined/Unknown
Pages (from-to)945-954
Number of pages10
Issue number8
Publication statusPublished - 2012

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