Re-stenosisNCT02809248
The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX- Stent Study)
A study testing ZES and BMS in people with Re-stenosis and Cirrhosis of the Liver, run by RWTH Aachen University.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Re-stenosis, Cirrhosis of the Liver
- What is being tested?
- ZES and BMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
- Conditions
- Re-stenosis, Cirrhosis of the Liver
- Being tested
- ZES, BMS
- Keywords
- LTX Study
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZESDevice
stent implantation (zotarolimus eluting stent)
BMSDevice
stent implantation (bare metal stent)
| Study group | Role | What they receive |
|---|---|---|
| coated stent | Active comparator | the patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent) Receives: Device: ZES |
| uncoated stent | Active comparator | the patient get a uncoated coronary stent implantation (BMS - bare metal stent) Receives: Device: BMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
the ideal stent (coated stent or uncoated stent)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completion31 Dec 2017
Why it stopped: Due to the small number of patients, none could be included in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-stenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Becker, MD, Principal investigator, Uniklinik RWTH Aachen, Med. Klinik I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809248
- Sponsor's protocol ID
- 15-123
- Status last verified
- Jul 2018
- First submitted
- 6 Jun 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence Cirrhosis of the Liver on the Coronary Re-stenosis (LTX-Stent Study)
- ClinicalTrials.gov ID
- NCT02809248
- Acronym / sponsor ID
- 15-123
- Conditions
- Re-stenosis, Cirrhosis of the Liver
- Keywords
- LTX Study
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the small number of patients, none could be included in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coated stent | Active comparator | Device: ZESthe patient get a coated coronary stent implantation (ZES - zotarolimus eluting stent) |
| uncoated stent | Active comparator | Device: BMSthe patient get a uncoated coronary stent implantation (BMS - bare metal stent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZESstent implantation (zotarolimus eluting stent) | Device | coated stent |
| BMSstent implantation (bare metal stent) | Device | uncoated stent |
Primary outcome
the ideal stent (coated stent or uncoated stent)
Time frame: 5 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Becker, MD principal investigator
Uniklinik RWTH Aachen, Med. Klinik I
Questions about this trial
What is this clinical trial studying?
A study testing ZES and BMS in people with Re-stenosis and Cirrhosis of the Liver, run by RWTH Aachen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the ideal stent (coated stent or uncoated stent) (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.