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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Cirrhosis of the Liver; Re-stenosis
• Intervention / Treatment: Device: ZES; Device: BMS

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: coated stent; the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent)	Device: ZES; stent implantation (zotarolimus eluting stent)
Active Comparator: uncoated stent; the patient get a uncoated coronary stent implantation (BMS - bare metal stent)	Device: BMS; stent implantation (bare metal stent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the ideal stent (coated stent or uncoated stent)	5 weeks

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Michael Becker, MD, Uniklinik RWTH Aachen, Med. Klinik I

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 18, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: LTX Study
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Pathological Conditions, Anatomical; Coronary Disease; Coronary Stenosis; Fibrosis; Liver Cirrhosis; Constriction, Pathologic; Coronary Restenosis
• Other Study ID Numbers: 15-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO