NCT02809248

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

1.4 years

First QC Date

June 6, 2016

Last Update Submit

July 13, 2018

Conditions

Re-stenosisCirrhosis of the Liver

Keywords

LTX Study

Outcome Measures

Primary Outcomes (1)

  • the ideal stent (coated stent or uncoated stent)

    5 weeks

Study Arms (2)

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

ZESDEVICE

stent implantation (zotarolimus eluting stent)

coated stent
BMSDEVICE

stent implantation (bare metal stent)

uncoated stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Becker, MD

    Uniklinik RWTH Aachen, Med. Klinik I

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 22, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share