Multivessel Stenting Versus Staged Revascularization With Zotarolimus-eluting Stent for STEMI (ZES for STEMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Russian Academy of Medical Sciences
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. Vladimir Ganyukov, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01781715
First received: January 29, 2013
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention Phase
ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease
Device: Zotarolimus-eluting coronary stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multivessel Stenting and Staged Revascularization for ST-elevation Myocardial Infarction Patients With Resolute Integrity Stents

Resource links provided by NLM:


Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • All death including cardiac and non cardiac death [ Time Frame: 30 days, 6 months and 12 montrhs ] [ Designated as safety issue: Yes ]
  • Recurrent MI [ Time Frame: 30 days, 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Any revascularizations (TLR or TVR) [ Time Frame: 30 days, 6 months and 12 months ] [ Designated as safety issue: Yes ]
  • Composite rate of all death, any MI and any repeat revascularization [ Time Frame: 30 days, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • stent thrombosis [ Time Frame: 30 days. 6 months and 12 months ] [ Designated as safety issue: Yes ]
    The incidence of stent thrombosis was assessed throughout the follow-up period, according to the conventional ARC (Academic Research Consortium) classification.

  • Non-TVR [ Time Frame: 30 days, 6 months and 12 months ] [ Designated as safety issue: No ]
    Any repeat revascularization of non target vessels


Other Outcome Measures:
  • Composite rate of all death, any MI and any repeat revascularization [ Time Frame: 30 days, 6 months and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multivessel stenting
This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions
Device: Zotarolimus-eluting coronary stent
Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients
Other Name: Resolute Integrity stent
Active Comparator: Staged revascularization
This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days)
Device: Zotarolimus-eluting coronary stent
Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients
Other Name: Resolute Integrity stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781715

Contacts
Contact: Vladimir Ganyukov, MD, PhD +79131273905 ganyukov@mail.ru
Contact: Roman Tarasov, MD, PhD +79235260446 roman.tarasov@mail.ru

Locations
Russian Federation
State Research Institute for Complex Issues of Cardiovascular Diseases Recruiting
Kemerovo, Kemerovo Region, Russian Federation, 650002
Contact: Vladimir Ganyukov, MD, PhD    +79131273905    ganyukov@mail.ru   
Contact: Roman Tarasov, MD, PhD    +79235260446    roman.tarasov@mail.ru   
Principal Investigator: Vladimir Ganyukov, MD, PhD         
Sponsors and Collaborators
Russian Academy of Medical Sciences
Medtronic
  More Information

No publications provided

Responsible Party: Dr. Vladimir Ganyukov, MD, PhD, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01781715     History of Changes
Other Study ID Numbers: Resolute Integrity for STEMI, ZES for STEMI
Study First Received: January 29, 2013
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Russian Academy of Medical Sciences:
STEMI, Multivessel Coronary Artery Disease, Primary PCI, multivessel stenting, zotarolimus-eluting stent

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014