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

Cirrhosis of the Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02809248
• Other study ID #: 15-123
• Status: Withdrawn
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2018
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis of the Liver
• Constriction, Pathologic
• Coronary Restenosis
• Fibrosis
• Liver Cirrhosis
• Re-stenosis

Intervention

Device:
• ZES
stent implantation (zotarolimus eluting stent)
• BMS
stent implantation (bare metal stent)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the ideal stent (coated stent or uncoated stent)		5 weeks