Intravascular ULTrasound Guided Versus Conventional Angiography Guided Strategy to Deploy Zotarolimus and Everolimus Eluting Third Generation Stents in the Long Coronary Artery Lesions: ULTRA-ZET Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Although first generation DES reduced instent restenosis, still remained the unsolved
      problems such as stent thrombosis and restenosis in the era of DES. Second generation DES had
      been developed to improve the biocompatibility of stent coating focused on polymer compared
      to first generation DES, so that second generation stents showed better outcomes compared
      with first generation DES. On the other hands, in third generation DES, further refinement of
      DES involved more flexible stent platform. Promus ElementTM (Everolimus eluting stent, Boston
      Scientific, Nastick, MA) and Resolute Integrity® (Zotarolimus eluting stent, Medtronic
      Vascular, Santa Rosa, CA) are the third generation drug eluting stents which are designed to
      increase flexibility. In previous randomized controlled studies, both of these stents have
      shown at least non-inferior angiographic and clinical outcomes compared to second generation
      DES. However, there is lack of data about comparison of angiographic and clinical outcomes
      between Promus ElementTM and Resolute Integrity®.

      IVUS is one of the widely used intracoronary imaging devices to provide more reproducible and
      accurate information about coronary anatomy than angiography in current practice.8 Optimal
      stent expansion assessed by intravascular ultrasound (IVUS) has been reported as an important
      factor to prevent stent thrombosis or restenosis.9 Accordingly, there have been many studies
      to evaluate the procedural or clinical benefit of IVUS guided angioplasty. However, The
      clinical benefit of IVUS-guided angioplasty with stent implantation is still in a
      controversy. In the previous studies, IVUS-guided stent implantation showed positive or
      negative beneficial effect on clinical outcomes according to their study subjects. However,
      the stents used in the previous studies are less useful in current practice of cardiology and
      there is lack of data of 3rd generation DES, which have different stent profiles and outcomes
      with their predecessors.

      Thus we would perform a prospective randomized study in order to compare the efficacy of
      IVUS-guided angioplasty with conventional angioplasty-guided procedure in the long coronary
      lesion. Our main hypothesis is IVUS-guided 3rd generation DES implantation in the long
      coronary lesions would have better clinical outcomes compared with conventional
      angiography-guided strategy. We also intend to assess the clinical outcomes after Promus
      ElementTM and Resolute Integrity® implantation.
    


Intervention name(s): IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion; Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion; Angiography guided percutaneous coronary angioplasty with Promus element stent implantation; Angiography guided percutaneous coronary angioplasty with Promus element stent implantation
Intervention type(s): Procedure; Device; Device; Procedure
Intervention description(s): Resolute integrity stent implantation (diameter from 2.5mm to 3.5mm, length 30, 34, 38mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.; Resolute integrity stent implantation (diameter from 2.5mm to 3.5mm, length 30, 34, 38mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.; Promus element stent implantation (diameter from 2.5mm to 3.5mm, length 28, 32, 36mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.; Promus element stent implantation (diameter from 2.5mm to 3.5mm, length 28, 32, 36mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intravenous ultrasound,; third generation drug-eluting stent