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Innovations in catheter and stent design

Plaque sealing and passivation with a mechanical self-expanding low outward force nitinol VShield device for the treatment of intravascular ultrasound and optical coherence tomography-derived thin cap fibroatheromas (TCFAS) in native coronary arteries

Aims: The aim of the pilot SECRITT trial was to evaluate the safety and feasibility of sealing the high risk IVUS and OCT-derived TCFAs with a dedicated nitinol self-expanding vShield device.

Methods and results: After screening with angiography, FFR, IVUS-VH and OCT 23 patients met enrollment 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). Baseline percent diameter stenosis was 33%+14%,FFR was 0.93+0.06, baseline plaque burden was 61%+9%, percent necrotic core in contact with the lumen was 35%+6% and average MLA was 6.8+2.4 mm2. At 6 months follow-up in shielded patients percent diameter stenosis further decreased to 19%+17% and FFR remained the same 0.93+0.05. Average late loss was 0.24 mm. Average baseline fibrous cap thickness was 48+12 microns. After shield placement at 6 months follow-up neo-cap formation was observed with average cap thickness of 201+168 microns. There were no dissections after shield placement and no plaque ruptures. In addition, mean stent area of 8.67 mm2 increased to 9.44 mm2, that is by 8.9% at 6 months follow-up. Number of malapposed struts decreased from 10.7% to 7.6% and the number of uncovered struts at 6 months was 8.1%. There were no device-related MACE events at 6 months follow-up.

Conclusions: High risk plaque passivation and sealing with v-Shield self expanding nitinol device appears feasible and safe. Long-term larger randomised study with streamlined screening criteria is needed to evaluate the efficacy of this approach over medical therapy.

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