The XLIMUS-DES in Very Complex Lesions
Condition: Coronary Atherosclerosis Due to Calcified Coronary Lesion; Chronic Total Occlusion of Coronary Artery
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and >90%
      of these failures are due to vessel tortuosity and/or calcification. The XLIMUS eluting
      coronary stent (CARDIONOVUM GmbH, Bonn, Germany) is a new type of endovascular prostheses
      characterised by better mechanical properties than traditional DES. This is a prospective,
      non-randomized, single-center pilot study, aiming to evaluate the performance of the XLIMUS
      DES in severely complex coronary lesions in real-world clinical practice.
    

Detailed description: 
      All consecutive patients who will undergo elective PCI in native coronary arteries at the
      Clinica Mediterranea (Naples, Italy) will be considered for eligility. Study participants
      wiil require to have symptomatic ischemic heart disease attributable to critical (that is,
      >70% visual estimate) stenotic lesions of native coronary arteries. Inclusion criteria in
      this pilot study are 1) chronic total occlusion (CTO), 2) severe target vessel calcification,
      and 3) severe target vessel tortuosity. CTO is defined as the presence of TIMI 0 flow within
      the occluded segment and angiographic or clinical evidence or high likelihood of an occlusion
      duration of ≥3 months. Calcification is defined severe when larger than 3x vessel diameter,
      and comprising the vessel wall totally in two perpendicular views. Tortuosity is defined
      severe when it satisfies the following criteria: one or more bends of 90° or more, or three
      or more bends of 45-90° proximal to the diseased segment.

      200 patients will be enrolled into the study. Stents will be implanted according to current
      clinical practice. Techniques attempted for facilitating stent delivery in such a complex
      lesions are: maximize guide catheter support, optimize predilatation of the stenosis, use of
      a stiffer guidewire. Specific tricks include: a) buddy-wire; anchoring balloon; GuideLiner
      catheter. In case of severe calcification, rotational atherectomy will be electively
      performed with the Rotablator® system (Boston Scientific Corporation, Natick, MA, U.S.A.).
      Following stent implantation, postdilatation will be performed in all instances with a
      non-compliant balloon. All patients will receive aspirin 325 mg and clopidogrel (75 mg daily)
      before stent deployment, with a loading dose (600 mg of clopidogrel) given to patients not
      pretreated. All patients will receive 70 IU/Kg intra-arterial bolus of unfractionated heparin
      in order to achieve and activated clotting time >250 seconds. Glycoprotein IIb/IIIa
      inhibitors will be administered according to operator preference. Estimated glomerular
      filtration rate (eGFR) will be calculated by applying the Levey Modification of Diet in Renal
      Disease (MDRD) formula. Chronic kidney disease was defined as a eGFR <60 ml/min/1.73 m2 .

      XLIMUS eluting-stent is made of cobalt chromium L 605 and the stent is available in a 6-, 8-,
      or 10-cell structure design (closed cell architecture). The struts thickness is 73µm. The
      6-cell design is for stenting of coronary artery diameter of 2.25mm-2.50mm, 8-cell structure
      is used for stenting of 2.75-3.50 mm artery diameters, and the 10-cell is for larger artery
      diameter lesions (up to 5mm). The XLIMUS has an innovative hydrophilic-coated shaft and an
      extra-low tip profile (crossing profile = 0.90 mm) to access the most tortuous lesions. The
      highly biocompatible polylactid acid (PLLA) drug containing release matrix degrades smoothly
      and provides an optimal release kinetic profile. Within 30 days, about 70% of the
      anti-proliferative drug is distributed into the surrounding arterial tissue of the stent
      struts, ensuring a highly effective inhibition of smooth muscle cell migration and
      proliferation. Pharmacokinetic study result confirm sustained anti-proliferative drug
      efficacy up to 120 days.

      The primary objective of the study is the assessment of the clinical performance of the
      XLILMUS DES, using the following criteria 1) device success, defined as the ability to insert
      the stent into the target lesion and the attainment of <20% residual stenosis (by visual
      estimate), 2) lesion success, defined as attainment of <20% residual stenosis of the target
      lesion using any percutaneous method, and 3) procedural success, defined as lesion success
      without any in-hospital and MACE.
    

Intervention name(s): XLimus
Intervention type(s): Device
Intervention description(s): Techniques attempted for facilitating stent delivery in such a complex lesions are: maximize guide catheter support, optimize predilatation of the stenosis, use of a stiffer guidewire. Specific tricks include: a) buddy-wire; anchoring balloon; GuideLiner catheter. In case of severe calcification, rotational atherectomy was electively performed with the Rotablator® system (Boston Scientific Corporation, Natick, MA, U.S.A.). Following stent implantation, postdilatation is performed in all instances with a non-compliant balloon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronary stent; outcome