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

NCT ID: NCT02809248

Last Updated: 2018-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Re-stenosis Cirrhosis of the Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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coated stent

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

Group Type ACTIVE_COMPARATOR

ZES

Intervention Type DEVICE

stent implantation (zotarolimus eluting stent)

uncoated stent

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

Group Type ACTIVE_COMPARATOR

BMS

Intervention Type DEVICE

stent implantation (bare metal stent)

Interventions

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ZES

stent implantation (zotarolimus eluting stent)

Intervention Type DEVICE

BMS

stent implantation (bare metal stent)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Becker, MD

Role: PRINCIPAL_INVESTIGATOR

Uniklinik RWTH Aachen, Med. Klinik I

Other Identifiers

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15-123

Identifier Type: -

Identifier Source: org_study_id

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