ST Elevation Myocardial Infarction, Multivessel Coronary Artery DiseasePhase 4ZES for STEMINCT01781715
Multivessel Stenting Versus Staged Revascularization With Zotarolimus-eluting Stent for STEMI
A Phase 4 study testing Zotarolimus-eluting coronary stent in people with ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The purpose of this study is to determine outcomes (death, myocardial infarction, target vessel revascularization (TVR), non-target vessel revascularization (non-TVR), stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and multivessel coronary artery disease undergoing multivessel… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease
- What is being tested?
- Zotarolimus-eluting coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- Sep 2011to Dec 2014
- 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
- Subject must be at least 18 years of age.
- Subject is able to verbally confirm understandings of risks, benefits of treatment of either multivessel stenting or staged PCI using the zotarolimus-eluting stent (Resolute Integrity™ Stent, Medtronic) and he or she or his or her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant stenoses (≥ 70%) of two or more than two of coronary arteries and requiring primary PCI for acute ST elevation myocardial infarction (STEMI) within 12hrs
- Target lesion(s) must be located in a native coronary artery with visually estimated diameter of less than 2.5 mm and more than 4.0 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention
Who cannot join
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin Aspirin Both Clopidogrel and Ticlopidine, Zotarolimus
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
- Non-cardiac comorbid conditions are present with life expectancy over 1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Acute heart failure Killip III-IV
- ≥ 50% left main stenosis
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, Kemerovo Oblast, 650002
Vladimir Ganyukov, MD, PhD, +79131273905, ganyukov@mail.ru
Roman Tarasov, MD, PhD, +79235260446, roman.tarasov@mail.ru
About this study
Official title: Multivessel Stenting and Staged Revascularization for ST-elevation Myocardial Infarction Patients With Resolute Integrity Stents
The purpose of this study is to determine outcomes (death, myocardial infarction, target vessel revascularization (TVR), non-target vessel revascularization (non-TVR), stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and multivessel coronary artery disease undergoing multivessel stenting or staged percutaneous coronary intervention with Zotarolimus-eluting stents
Read the detailed description
Multivessel coronary artery disease has been reported to occur in 40 to 67% of ST elevation myocardial infarction (STEMI) patients. Multivessel coronary artery disease (MVCD) patients, who have experienced STEMI, are at a high risk of major cardiovascular events (MACE) within one year after primary PCI. While MACE incidence in patients with one-vessel coronary artery disease is about 14.5%, patients with two- and three-vessel lesions experience MACE in 19.5% and 23.6% of cases, respectively. The risk of death in a 5-year follow-up increases two-fold in MVCD patients. This risk can be partly explained by slower recovery of left ventricular function and progression of left ventricular pathological remodeling process after MI. In addition, the mere presence of MVCD has been shown to be associated with MACE development in the long-term period. There are several treatment strategies for ST-elevation myocardial infarction (STEMI) patients with MVCD: infarct related artery (IRA)-only percutaneous coronary intervention (PCI), multivessel stenting in the primary PCI setting and staged revascularisation. The current guidelines for STEMI revascularisation give no definite instructions on the need for concurrent non-IRA intervention in patients with stable haemodynamics. At present, there are not clinical trials testing the current Zotarolimus-eluting stents (ZES) in STEMI patients with MVCD undergoing primary PCI for different strategies of revascularization.
- Being tested
- Zotarolimus-eluting coronary stent
- Keywords
- STEMI, Multivessel Coronary Artery Disease, Primary PCI, multivessel stenting, zotarolimus-eluting stent
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zotarolimus-eluting coronary stentDevice
Also called Resolute Integrity stent
Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients
| Study group | Role | What they receive |
|---|---|---|
| Multivessel stenting | Experimental | This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions Receives: Device: Zotarolimus-eluting coronary stent |
| Staged revascularization | Active comparator | This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days) Receives: Device: Zotarolimus-eluting coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
All death including cardiac and non cardiac death
Measured: 30 days, 6 months and 12 montrhs
Recurrent MI
Measured: 30 days, 6 months and 12 months
Any revascularizations (TLR or TVR)
Measured: 30 days, 6 months and 12 months
Composite rate of all death, any MI and any repeat revascularization
Measured: 30 days, 6 months and 12 months
Secondary outcomes (2)
stent thrombosis
The incidence of stent thrombosis was assessed throughout the follow-up period, according to the conventional ARC (Academic Research Consortium) classification.
Measured: 30 days. 6 months and 12 months
Non-TVR
Any repeat revascularization of non target vessels
Measured: 30 days, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial Infarction, Multivessel Coronary Artery DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Dr. Vladimir Ganyukov, Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781715
- Sponsor's protocol ID
- Resolute Integrity for STEMI
- Other IDs
- ZES for STEMI
- Acronym
- ZES for STEMI
- Status last verified
- Jan 2013
- First submitted
- 29 Jan 2013
- Last updated
- 1 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivessel Stenting and Staged Revascularization for ST-elevation Myocardial Infarction Patients With Resolute Integrity Stents
- ClinicalTrials.gov ID
- NCT01781715
- Acronym / sponsor ID
- ZES for STEMI / Resolute Integrity for STEMI
- Keywords
- STEMI, Multivessel Coronary Artery Disease, Primary PCI, multivessel stenting, zotarolimus-eluting stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Feb 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 purpose of this study is to determine outcomes (death, myocardial infarction, target vessel revascularization (TVR), non-target vessel revascularization (non-TVR), stent-thrombosis) of 120 consecutive patients with ST elevation myocardial infarction and multivessel coronary artery disease undergoing multivessel stenting or staged percutaneous coronary intervention with Zotarolimus-eluting stents
Detailed description
Multivessel coronary artery disease has been reported to occur in 40 to 67% of ST elevation myocardial infarction (STEMI) patients. Multivessel coronary artery disease (MVCD) patients, who have experienced STEMI, are at a high risk of major cardiovascular events (MACE) within one year after primary PCI. While MACE incidence in patients with one-vessel coronary artery disease is about 14.5%, patients with two- and three-vessel lesions experience MACE in 19.5% and 23.6% of cases, respectively. The risk of death in a 5-year follow-up increases two-fold in MVCD patients. This risk can be partly explained by slower recovery of left ventricular function and progression of left ventricular pathological remodeling process after MI. In addition, the mere presence of MVCD has been shown to be associated with MACE development in the long-term period. There are several treatment strategies for ST-elevation myocardial infarction (STEMI) patients with MVCD: infarct related artery (IRA)-only percutaneous coronary intervention (PCI), multivessel stenting in the primary PCI setting and staged revascularisation. The current guidelines for STEMI revascularisation give no definite instructions on the need for concurrent non-IRA intervention in patients with stable haemodynamics. At present, there are not clinical trials testing the current Zotarolimus-eluting stents (ZES) in STEMI patients with MVCD undergoing primary PCI for different strategies of revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multivessel stenting | Experimental | Device: Zotarolimus-eluting coronary stentThis group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions |
| Staged revascularization | Active comparator | Device: Zotarolimus-eluting coronary stentThis group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject must be at least 18 years of age.
- Subject is able to verbally confirm understandings of risks, benefits of treatment of either multivessel stenting or staged PCI using the zotarolimus-eluting stent (Resolute Integrity™ Stent, Medtronic) and he or she or his or her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant stenoses (≥ 70%) of two or more than two of coronary arteries and requiring primary PCI for acute ST elevation myocardial infarction (STEMI) within 12hrs
- Target lesion(s) must be located in a native coronary artery with visually estimated diameter of less than 2.5 mm and more than 4.0 mm.
- Target lesion(s) must be amenable for percutaneous coronary intervention
Key exclusion criteria (6 listed)
- The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin Aspirin Both Clopidogrel and Ticlopidine, Zotarolimus
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 6 months post enrollment.
- Non-cardiac comorbid conditions are present with life expectancy over 1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Acute heart failure Killip III-IV
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 |
|---|---|---|
| Zotarolimus-eluting coronary stentAlso: Resolute Integrity stentMultivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients | Device | Multivessel stenting, Staged revascularization |
Primary outcome
All death including cardiac and non cardiac death
Time frame: 30 days, 6 months and 12 montrhs
Recurrent MI
Time frame: 30 days, 6 months and 12 months
Any revascularizations (TLR or TVR)
Time frame: 30 days, 6 months and 12 months
Composite rate of all death, any MI and any repeat revascularization
Time frame: 30 days, 6 months and 12 months
2 secondary outcomes
stent thrombosis
Time frame: 30 days. 6 months and 12 months
Non-TVR
Time frame: 30 days, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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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.
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 Zotarolimus-eluting coronary stent in people with ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease, run by Russian Academy of Medical Sciences at 1 site in Russia.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Feb 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Ganyukov, MD, PhD (+79131273905, ganyukov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All death including cardiac and non cardiac death (time frame: 30 days, 6 months and 12 montrhs). The study lists 4 primary outcomes in all. 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 1 Feb 2013.