Late Acquired Stent MalapositionPhase 4NCT02018991
Late Acquired Malaposition and Different Polymers
A Phase 4 study testing Everolimus-Eluting Stent (EES), Zotarolimus-Eluting-Stent (ZES) and Biolimus-Eluting-Stent (BES) in people with Late Acquired Stent Malaposition, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Late Acquired Stent Malaposition
- What is being tested?
- Everolimus-Eluting Stent (EES), Zotarolimus-Eluting-Stent (ZES) and Biolimus-Eluting-Stent (BES)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2010to Aug 2013
- Phase
- Phase 4
- 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
- Patients who underwent an elective treatment of a coronary lesion > 20mm with a DES
Who cannot join
- chronic renal failure (serum creatinine ≥ 2.5mg/dl)
- restenotic lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Predictors for Late Acquired Stent Malaposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - a Prospective, Randomized Comparison Using Optical Coherence Tomography
The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.
Read the detailed description
please see brief summary
- Conditions
- Late Acquired Stent Malaposition
- Being tested
- Everolimus-Eluting Stent (EES), Zotarolimus-Eluting-Stent (ZES), Biolimus-Eluting-Stent (BES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus-Eluting Stent (EES)Procedure or surgery
Patients treated with EES
Zotarolimus-Eluting-Stent (ZES)Procedure or surgery
Patients treated with ZES
Biolimus-Eluting-Stent (BES)Procedure or surgery
Patients treated with BES
| Study group | Role | What they receive |
|---|---|---|
| Everolimus-Eluting-Stent (EES) | Active comparator | Patients treated with EES Receives: Procedure: Everolimus-Eluting Stent (EES) |
| Zotarolimus-Eluting-Stent (ZES) | Active comparator | Patients treated with ZES Receives: Procedure: Zotarolimus-Eluting-Stent (ZES) |
| Biolimus-Eluting-Stent (BES) | Active comparator | Patients treated with BES Receives: Procedure: Biolimus-Eluting-Stent (BES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stent struts with late acquired malaposition
Measured: 1 year after stent implantation
Secondary outcomes (1)
number of stent struts with late acquired malaposition
Measured: 2 years after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startOct 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Acquired Stent MalapositionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ. Prof. Dr. Thomas Neunteufl, Medical University of Vienna
- Investigators
- Thomas Neunteufl, Prof. Dr., Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018991
- Sponsor's protocol ID
- MUW-0001
- Status last verified
- Dec 2013
- First submitted
- 17 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predictors for Late Acquired Stent Malaposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - a Prospective, Randomized Comparison Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02018991
- Acronym / sponsor ID
- MUW-0001
- Conditions
- Late Acquired Stent Malaposition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Dec 2013 (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 polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.
Detailed description
please see brief summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Everolimus-Eluting-Stent (EES) | Active comparator | Procedure: Everolimus-Eluting Stent (EES)Patients treated with EES |
| Zotarolimus-Eluting-Stent (ZES) | Active comparator | Procedure: Zotarolimus-Eluting-Stent (ZES)Patients treated with ZES |
| Biolimus-Eluting-Stent (BES) | Active comparator | Procedure: Biolimus-Eluting-Stent (BES)Patients treated with BES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent an elective treatment of a coronary lesion > 20mm with a DES
Key exclusion criteria (2 listed)
- chronic renal failure (serum creatinine ≥ 2.5mg/dl)
- restenotic lesions
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 |
|---|---|---|
| Everolimus-Eluting Stent (EES)Patients treated with EES | Procedure or surgery | Everolimus-Eluting-Stent (EES) |
| Zotarolimus-Eluting-Stent (ZES)Patients treated with ZES | Procedure or surgery | Zotarolimus-Eluting-Stent (ZES) |
| Biolimus-Eluting-Stent (BES)Patients treated with BES | Procedure or surgery | Biolimus-Eluting-Stent (BES) |
Primary outcome
Number of stent struts with late acquired malaposition
Time frame: 1 year after stent implantation
1 secondary outcome
number of stent struts with late acquired malaposition
Time frame: 2 years after stent implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
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.
Thomas Neunteufl, Prof. Dr. principal investigator
PI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Everolimus-Eluting Stent (EES), Zotarolimus-Eluting-Stent (ZES) and Biolimus-Eluting-Stent (BES) in people with Late Acquired Stent Malaposition, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of stent struts with late acquired malaposition (time frame: 1 year after stent implantation). 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 30 Dec 2013.