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The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)

Primary Purpose

Re-stenosis, Cirrhosis of the Liver

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ZES
BMS
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Re-stenosis focused on measuring LTX Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • male and female patients with a severe dysfunction of liver
  • patient is planned a coronary stent implantation
  • adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
  • written informed consent prior to study participation

Exclusion Criteria:

  • younger than 18 years
  • pregnancy and breast-feeding
  • acute cardiac syndrome
  • contraindication against an intracardiac catheter
  • persons in dependence from the sponsor or working with the sponsor
  • participation in a parallel interventional clinical trial
  • patient has been committed to an institution by legal or regulatory order

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    coated stent

    uncoated stent

    Arm Description

    the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent)

    the patient get a uncoated coronary stent implantation (BMS - bare metal stent)

    Outcomes

    Primary Outcome Measures

    the ideal stent (coated stent or uncoated stent)

    Secondary Outcome Measures

    Full Information

    First Posted
    June 6, 2016
    Last Updated
    July 13, 2018
    Sponsor
    RWTH Aachen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02809248
    Brief Title
    The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)
    Official Title
    The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX-Stent Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Due to the small number of patients, none could be included in the study.
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    RWTH Aachen University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of the study is to choose an optimal stent and to get further knowledge about the mechanisms of the engraftment of a stent. The occurrence of a hyperplasia of neointima can be minimized by application of a coated stent and a concurrent safety four weekly dual thrombocytes therapy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Re-stenosis, Cirrhosis of the Liver
    Keywords
    LTX Study

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    coated stent
    Arm Type
    Active Comparator
    Arm Description
    the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent)
    Arm Title
    uncoated stent
    Arm Type
    Active Comparator
    Arm Description
    the patient get a uncoated coronary stent implantation (BMS - bare metal stent)
    Intervention Type
    Device
    Intervention Name(s)
    ZES
    Intervention Description
    stent implantation (zotarolimus eluting stent)
    Intervention Type
    Device
    Intervention Name(s)
    BMS
    Intervention Description
    stent implantation (bare metal stent)
    Primary Outcome Measure Information:
    Title
    the ideal stent (coated stent or uncoated stent)
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: male and female patients with a severe dysfunction of liver patient is planned a coronary stent implantation adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel written informed consent prior to study participation Exclusion Criteria: younger than 18 years pregnancy and breast-feeding acute cardiac syndrome contraindication against an intracardiac catheter persons in dependence from the sponsor or working with the sponsor participation in a parallel interventional clinical trial patient has been committed to an institution by legal or regulatory order
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Becker, MD
    Organizational Affiliation
    Uniklinik RWTH Aachen, Med. Klinik I
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)

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