ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease Clinical Trial
— ZES for STEMIOfficial 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
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | State Research Institute for Complex Issues of Cardiovascular Diseases | Kemerovo | Kemerovo Region |
| Lead Sponsor | Collaborator |
|---|---|
| Russian Academy of Medical Sciences | Medtronic |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Composite rate of all death, any MI and any repeat revascularization | 30 days, 6 months and 12 months | Yes | |
| Primary | All death including cardiac and non cardiac death | 30 days, 6 months and 12 montrhs | Yes | |
| Primary | Recurrent MI | 30 days, 6 months and 12 months | Yes | |
| Primary | Any revascularizations (TLR or TVR) | 30 days, 6 months and 12 months | Yes | |
| Primary | Composite rate of all death, any MI and any repeat revascularization | 30 days, 6 months and 12 months | Yes | |
| Secondary | stent thrombosis | The incidence of stent thrombosis was assessed throughout the follow-up period, according to the conventional ARC (Academic Research Consortium) classification. | 30 days. 6 months and 12 months | Yes |
| Secondary | Non-TVR | Any repeat revascularization of non target vessels | 30 days, 6 months and 12 months | No |