Document Detail

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).
MedLine Citation:
PMID:  22669133     Owner:  NLM     Status:  Publisher    
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-months 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.
Joanna J Wykrzykowska; Roberto Diletti; Juan Luis Gutierrez-Chico; Robert Jan van Geuns; Wim J van der Giessen; Steven Ramcharitar; H Eric Duckers; Carl Schultz; Pim de Feyter; Martin van der Ent; Evelyn Regar; Peter de Jaegere; Hector M Garcia-Garcia; Rawindra Pawar; Nieves Gonzalo; Jurgen Ligthart; Jean de Schepper; Nico van den Berg; Krzysztof Milewski; Juan Granada; Patrick W Serruys
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-6-6
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  -     ISSN:  1969-6213     ISO Abbreviation:  -     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-6-6     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
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