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Title: 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). Author: Wykrzykowska JJ, Diletti R, Gutierrez-Chico JL, van Geuns RJ, van der Giessen WJ, Ramcharitar S, Duckers HE, Schultz C, de Feyter P, van der Ent M, Regar E, de Jaegere P, Garcia-Garcia HM, Pawar R, Gonzalo N, Ligthart J, de Schepper J, van den Berg N, Milewski K, Granada JF, Serruys PW. Journal: EuroIntervention; 2012 Dec 20; 8(8):945-54. PubMed ID: 22669133. Abstract: 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 33.2±13.5%, FFR was 0.93±0.06. At six-month follow-up in shielded patients percent diameter stenosis further decreased to 18.7±16.9% and FFR remained the same 0.93±0.05. Average late loss was 0.24±0.13 mm. Average baseline fibrous cap thickness was 48±12 µm. After shield placement at six-month follow-up neo-cap formation was observed with average cap thickness of 201±168 µm. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.76±2.16 mm2 increased to 9.45±2.30 mm2, that is by 9% at six-month follow-up. The number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at six months was 8.1%. There were no device-related major adverse cardiovascular events (MACE) events at six-month follow-up. 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.[Abstract] [Full Text] [Related] [New Search]