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

R

RWTH Aachen University

Status

Withdrawn

Conditions

Re-stenosis
Cirrhosis of the Liver

Treatments

Device: ZES
Device: BMS

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

coated stent
Active Comparator group
Description:
the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent)
Treatment:
Device: ZES
uncoated stent
Active Comparator group
Description:
the patient get a uncoated coronary stent implantation (BMS - bare metal stent)
Treatment:
Device: BMS

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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