The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)
Not Applicable
Withdrawn
- Conditions
- Cirrhosis of the LiverRe-stenosis
- Interventions
- Device: BMSDevice: ZES
- Registration Number
- NCT02809248
- Lead Sponsor
- RWTH Aachen University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description uncoated stent BMS the patient get a uncoated coronary stent implantation (BMS - bare metal stent) coated stent ZES the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent)
- Primary Outcome Measures
Name Time Method the ideal stent (coated stent or uncoated stent) 5 weeks
- Secondary Outcome Measures
Name Time Method