eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries (NCT02765646) | Clinical Trial Compass
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eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries
Germany100 participantsStarted 2016-05
Plain-language summary
The objective of this study is to demonstrate the clinical performance of the Tryton Side Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to treat de novo bifurcated lesions involving both the Left Main (LM) and Circumflex Coronary Artery(LCX).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is ≥18 years old;
✓. Patient is eligible for percutaneous coronary intervention (PCI);
✓. Patient is an acceptable candidate for CABG;
✓. Clinical evidence of ischemic heart disease and / or a positive functional registry. Documented stable angina pectoris (Canadian cardiovascular society classification (CCS) 1, 2, 3 or 4), unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia;
✓. Single high grade de novo bifurcation lesion with ≥50% and \<100% stenosis in the distal part of left main, requiring stent placement across LCx Ostium, with TIMI flow \> 2 by visual estimation;
✓. The target lesion length must be able to be covered by a single main vessel stent ≥ 5.0mm and ≤ 32 mm in the main vessel and ≤ 32 mm in the side branch (visual estimate) and be covered by one Tryton stent and up to one DES in the side branch;
✓. The reference vessel diameter of the main branch must be ≥ 2.5mm and ≤ 4.0 mm (visual estimate) and reference vessel diameter of the side branch must be ≥ 2.25mm and ≤ 3.5 mm (visual estimate);
✓. If required by local regulations, the patient had been informed of the nature of the registry, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC) of the respective clinical site;
. Documented left ventricular ejection fraction (LVEF) ≤30%;
✕. Evidence of an acute myocardial infarction within 48 hours of the intended treatment;
✕. Known allergies to the following: Acetylsalicylic acid (ASA) (Aspirin®), Clopidogrel bisulfate (Plavix®.) or Ticlopidine (Ticlid®.), Heparin, contrast agent (that cannot be adequately pre-medicated);
✕. Acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or \>150μmol/L);
✕. Target vessel has angiographic evidence of thrombus;
✕. Previous interventional procedure (less than 1 year) anywhere within the left main artery including the bifurcation to the LAD and/or LCX;