The Influence Cirrhosis of the Liver on the Coronary Re-s... | NCT02809248

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

NCT02809248

Sponsor

RWTH Aachen University

Status

Withdrawn

Last Update Posted

Jul 17, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Re-stenosis
Cirrhosis of the Liver

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to the small number of patients, none could be included in the study.

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jun 6, 2016

First Submission Date that Met QC Criteria

Jun 18, 2016

First Posted Date

Jun 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2018

Last Update Posted Date

Jul 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
coated stent	Active Comparator	the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent)	Device: ZES
uncoated stent	Active Comparator	the patient get a uncoated coronary stent implantation (BMS - bare metal stent)	Device: BMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ZES	Device	stent implantation (zotarolimus eluting stent)	coated stent

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Becker, MD	Uniklinik RWTH Aachen, Med. Klinik I	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided