CRE8 in All Comers Patients
Condition: Consecutive Subjects Who Are Suitable for a Coronary; Angioplasty of de Novo Lesion(s) in Native Coronary; Arteries Should be Screened for Eligibility.; A Total Number of 200 Patients Fulfilling the Selection; Criteria and Willing to Sign the Informed Consent Should; be Enrolled in the Trial.
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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.
    

Intervention name(s): CR8 a drug eluting coronary stent
Intervention type(s): Device
Intervention description(s): a drug eluting coronary device, made of Cobalt-Chromium alloy and integrally coated with i-Carbofilm™, loaded with formulated Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary angioplasty; de novo lesion