A Total Number of 200 Patients Fulfilling the Selection Clinical Trial
Official title:
CRE8 in All Comers Patients
The purpose of the study is to evaluate clinical performances of Cre8 in all comer population in Subjects over 18 years old who are undergoing a clinically indicated coronary angiogram and angioplasty on de-novo lesion located in native coronary arteries
The development, clinical validation, and widespread use of drug-eluting stents have
revolutionized the treatment of patients with coronary artery disease. Large scale,
prospective, multicenter double-blind randomized trials have provided strong evidence that
sirolimus-eluting stents, paclitaxel-eluting stents, and zotarolimus-eluting stents
significantly reduce angiographic restenosis and enhance event-free survival compared with
bare-metal stents after implantation in native coronary arteries1. However, higher rates of
late and very late stent thrombosis with SES and PES, likely due to delayed and incomplete
endothelialization compared with BMS, have raised safety concerns with DES as a class.
Therefore, alongside clinical investigations, histopathological evaluations were conducted
on the coronary arteries of patients who died after DES implantation to examine the healing
status of the vessel. The evidence obtained suggested that the polymer components used to
carry the drug in the first generation of DES may be associated with a local inflammatory
response, associated with localized hypersensitivity and eosinophil infiltration, with
consequent alteration of the vessel wall and delay in the formation of the endothelium.
Because specific stent design and/or polymer features may impact DES performance, numerous
studies have focused on the comparative assessment of various DES, with conflicting results.
The clinical need thus exists for enhanced stent designs which offer improved safety and
efficacy profiles compared to the earlier stent platforms.
new technologies have been developed which have led to the creation of devices with delivery
systems based on the use of more biocompatible or bioabsorbable polymers and cytostatic
drugs similar to sirolimus. The clinical data obtained with this second generation have
demonstrated, in all devices tested, no less efficacy than first-generation DES, and a
better safety profile, although not statistically significant.Concerning the most widely
used second generation DES,after a small first-in-man trial, its safety and efficacy was
further studied in larger randomized trials on patients with non-complex lesions in which
EES was compared to PES, proving its angiographic superiority and clinical non-inferiority.
A step forward, in assessing the clinically significant differences among different DES, was
done with a new randomized trial comparing EES versus PES, powered for testing superiority
in clinical outcomes and of sufficient magnitude to provide data on patient subgroups,
particularly patients with diabetes. At present, a third-generation of DES, developed to
minimize the possible side effects related to the presence of the polymer, is being
evaluated in humans. To avoid the presence of the polymer on the surface of the device,
different platforms are being evaluated: those with a porous surface onto which the pure
drug is placed and those with holes closed towards the intraluminal part by a bioabsorbable
polymer, onto which the drug is loaded. A third option to avoid the need of polymers has
been used in the new CRE8 DES, featuring a polymer free platform with abluminal reservoirs
to release the Amphilimus formulation. This device has been tested against Taxus Liberté in
a randomized clinical trial, to assess the non-inferiority angiographic efficacy results.
The 6month angiographic analysis, demonstrates that the primary study endpoint has been
achieved, showing that CRE8 was not inferior to Taxus Liberté in terms of efficacy
performances.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment