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Optical Coherence Tomography Predictors for Recurrent Restenosis After Paclitaxel-Coated Balloon Angioplasty for Drug-Eluting Stent Restenosis Percutaneous coronary intervention with drug-coated balloon-only strategy in stable coronary artery disease and in acute coronary syndromes: An all-comers registry study Comparison of the safety and efficacy of two types of drug-eluting balloons (RESTORE DEB and SeQuent® Please) in the treatment of coronary in-stent restenosis: study protocol for a randomized controlled trial (RESTORE ISR China) Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results Comparison of new-generation drug-eluting stents versus drug-coated balloon for in-stent restenosis: a meta-analysis of randomised controlled trials Applications of left ventricular strain measurements to patients undergoing chemotherapy Long-term clinical outcomes after treatment of stent restenosis with two drug-coated balloons Angiographic quantitative flow ratio-guided coronary intervention (FAVOR III China): a multicentre, randomised, sham-controlled trial Orbital atherectomy for the treatment of small (2.5mm) severely calcified coronary lesions: ORBIT II sub-analysis

Clinical Trial2011 Apr;6(9):1037-45.

JOURNAL:EuroIntervention. Article Link

First-in-man evaluation of intravascular optical frequency domain imaging (OFDI) of Terumo: a comparison with intravascular ultrasound and quantitative coronary angiography

Okamura T, Onuma Y, Garcia-Garcia HM et al. Keywords: IVUS; stents; OCT; coronary imaging; optical frequency domain imaging

ABSTRACT


AIMS The objective of this study is to evaluate the feasibility and safety of imaging human coronary arteries in vivo by optical frequency domain imaging (OFDI) in comparison to intravascular ultrasound (IVUS). OFDI has been recently developed to overcome the limitations of conventional time-domain optical coherence tomography (OCT), namely the need for proximal balloon occlusion. The Terumo-OFDI system is capable of acquiring images with high-speed automated pullback (up to 40 mm/sec) and requires only a short injection (3-4 sec) of small amount of x-ray contrast (9-16 ml).


METHODS AND RESULTS - Nineteen patients who underwent stent implantation were enrolled. IVUS/OFDI were performed before and after stenting. The incidences of any adverse event and angiographic adverse findings were recorded. Lumen area (LA) was measured by IVUS and OFDI at 1 mm intervals in the stented segments (n=19) as well as in the proximal, distal, and to-be-stented segments (n=40). In addition, lumen area in the stented segment was also measured by edge (E-) and video-densitometric (VD-) quantitative coronary angiography (QCA). The OFDI images were obtained without any adverse event related to imaging procedures. Post stenting (n=19), minimal LA (MLA) measured by OFDI (5.84 ± 1.89 mm2) was larger than that of E-QCA (4.16 ± 1.46 mm2, p<0.001) and VD-QCA (4.92 ± 1.55 mm2, p<0.05). It was smaller than IVUS-MLA (6.26 ± 2.01 mm2, N.S.) but the correlation between the two measurements was highly significant (R2=0.82, p<0.001).

CONCLUSIONS - The OFDI imaging is feasible both before and after stenting and has a promising safety profile. The OFDI provided clear high resolution images and robust lumen measurements.