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

RWTH Aachen University

Status: Withdrawn

Conditions: Re-stenosis; Cirrhosis of the Liver

Treatments: Device: ZES; Device: BMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02809248

15-123

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)

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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