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XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization (XLIMIT)

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ClinicalTrials.gov Identifier: NCT03745053
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Mediolanum Cardio Research
Information provided by (Responsible Party):
Cardionovum GmbH

Tracking Information
First Submitted Date  ICMJE November 9, 2018
First Posted Date  ICMJE November 19, 2018
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE February 5, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
In-stent neointimal volume [ Time Frame: 6-month follow-up ]
In-stent neointimal volume at 6-month follow-up, measured with OCT, as assessed by the Core-Lab. Neointimal volume will be calculated in all analyzed cross-sections and volumetric measurements and in stent neointimal volume will be compared in the two groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03745053 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2018)
  • Neointimal area [ Time Frame: 6-month follow-up ]
    Neointimal area calculated at the site of minimal lumen area measured with OCT
  • Number of Target lesion failure [ Time Frame: 12-months follow-up ]
    composite of Cardiac death, target-vessel Myocardial infarction (MI) and clinically indicated target lesion revascularization (TLR)
  • Number of patients experiencig Cardiac death [ Time Frame: 12-months follow-up ]
    Any death due to proximate cardiac cause (eg, MI, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death
  • Number of Target-vessel Myocardial infarction [ Time Frame: 12-months follow-up ]
    any MI that, irrespective of the time after the index procedure, is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause. Type of acute MI is classified according to the Joint ESC/ACCF/AHA/ WHF Joint Task Force for the Universal Definition of Myocardial Infarction
  • Number of Target-lesion revascularization [ Time Frame: 12-months follow-up ]
    repeat revascularization will be defined as any repeat PCI or new coronary artery bypass graft (CABG) surgery within the first year post-PCI
  • Number of Stent thrombosis [ Time Frame: 12-months follow-up ]
    This is defined according to classification proposed by the Academic Research Consortium
  • Percentage of Device success at 24 hours [ Time Frame: 24 hours ]
    deployment of the assigned stents without system failure or device-related complication
  • Percentage of Lesion success at 24 hours [ Time Frame: 24 hours ]
    attainment of <50% residual stenosis of the target lesion using post-PCI
  • Percentage of Procedural success at 24 hours [ Time Frame: 24 hours ]
    lesion success without the occurrence of major adverse cardiac event (MACE) during the hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization
Official Title  ICMJE XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization
Brief Summary The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty
Detailed Description The present clinical investigation is designed as a prospective, multicentre, international, randomized, open label, 2-arm parallel group, trial in patients undergoing Percutaneous Coronary Intervention (PCI) comparing Xlimus DES versus Synergy DES with respect to optical coherence tomography (OCT) derived measures at 6-month Follow Up (FU) and clinical events at 12 months after procedure. A total of 180 patients will be recruited and randomized in the two groups in a 2:1 ratio. After index procedure, patients will be followed up by angiographic follow-up at 6 months and clinical follow-up at 12 months.The primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized multi-centre controlled trial
Masking: Single (Outcomes Assessor)
Masking Description:
The members of the Event Adjudication Committee and the Core Lab will be blinded to the patient assignment.
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: Xlimus DES Implantation during coronary angioplasty
    Xlimus DES Implantation during coronary angioplasty
  • Device: Synergy DES Implantation during coronary angioplasty
    Synergy DES Implantation during coronary angioplasty
Study Arms  ICMJE
  • Experimental: XLIMUS DES
    Xlimus DES Implantation during coronary angioplasty
    Intervention: Device: Xlimus DES Implantation during coronary angioplasty
  • Active Comparator: Synergy DES
    Synergy DES Implantation during coronary angioplasty
    Intervention: Device: Synergy DES Implantation during coronary angioplasty
Publications * Testa L, Pero G, Bollati M, Matteo C, Popolo Rubbio A, Cuman M, Moreno R, Serra A, Gomez JA, Bedogni F. XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial. Int J Cardiol Heart Vasc. 2019 Apr 28;23:100363. doi: 10.1016/j.ijcha.2019.100363. eCollection 2019 Jun.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2018)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age≥18
  2. Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI.
  3. PCI considered appropriate and feasible
  4. Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for implantation with either study stent (no limitation on the number of treated lesions, vessel and lesion length);
  5. Patient provides written informed consent
  6. Patient agrees to all required follow-up procedures and visits.
  7. Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm

Exclusion Criteria:

  1. The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus or its derivatives, everolimus or structurally-related compounds, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled);
  2. Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum;
  3. Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer;
  4. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study and not using adequate contraceptive methods;
  5. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
  6. Previous coronary intervention on target vessel in the 3-months prior to enrollment;
  7. Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
  8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
  9. Previously documented left ventricular ejection fraction (LVEF) <30%;
  10. Evident cardiogenic shock before randomization;
  11. Patients with left main stem stenosis (>50% by visual estimate);
  12. In-stent restenosis;
  13. ST-segment elevation MI;
  14. Chronic total occlusion/ heavily calcified lesions
  15. Culprit lesion to a Saphenous Vein graft
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nadia Moffa, BSc 0039 026125141 moffa@mcr-med.com
Contact: Maria Cristina Jori, MD 0039 026125141 jori@mcr-med.com
Listed Location Countries  ICMJE Italy,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03745053
Other Study ID Numbers  ICMJE XLIMIT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cardionovum GmbH
Study Sponsor  ICMJE Cardionovum GmbH
Collaborators  ICMJE Mediolanum Cardio Research
Investigators  ICMJE
Principal Investigator: Luca Testa, MD IRCCS Policlinico S. Donato
PRS Account Cardionovum GmbH
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP