Back to results

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

Primary Purpose

ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Status

Unknown status

Phase

Phase 4

Locations

Russian Federation

Study Type

Interventional

Intervention

Zotarolimus-eluting coronary stent

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease focused on measuring STEMI, Multivessel Coronary Artery Disease, Primary PCI, multivessel stenting, zotarolimus-eluting stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

State Research Institute for Complex Issues of Cardiovascular DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multivessel stenting

Staged revascularization

Arm Description

This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions

This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days)

Outcomes

Primary Outcome Measures

All death including cardiac and non cardiac death

Recurrent MI

Any revascularizations (TLR or TVR)

Composite rate of all death, any MI and any repeat revascularization

Secondary Outcome Measures

stent thrombosis

The incidence of stent thrombosis was assessed throughout the follow-up period, according to the conventional ARC (Academic Research Consortium) classification.

Non-TVR

Any repeat revascularization of non target vessels

Full Information

NCT ID

NCT01781715

First Posted

January 29, 2013

Last Updated

January 30, 2013

Sponsor

Russian Academy of Medical Sciences

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT01781715

Brief Title

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

Acronym

ZES for STEMI

Official Title

Multivessel Stenting and Staged Revascularization for ST-elevation Myocardial Infarction Patients With Resolute Integrity Stents

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Russian Academy of Medical Sciences

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Keywords

STEMI, Multivessel Coronary Artery Disease, Primary PCI, multivessel stenting, zotarolimus-eluting stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multivessel stenting

Arm Type

Experimental

Arm Description

This group comprises the patients who undergo a one-time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions

Arm Title

Staged revascularization

Arm Type

Active Comparator

Arm Description

This group comprises the patients who undergo PCI of only the culprit lesion and staged nonculprit PCI at a later date (3-15 days)

Intervention Type

Device

Intervention Name(s)

Zotarolimus-eluting coronary stent

Other Intervention Name(s)

Resolute Integrity stent

Intervention Description

Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients

Primary Outcome Measure Information:

Title

All death including cardiac and non cardiac death

Time Frame

30 days, 6 months and 12 montrhs

Title

Recurrent MI

Time Frame

30 days, 6 months and 12 months

Title

Any revascularizations (TLR or TVR)

Time Frame

30 days, 6 months and 12 months

Title

Composite rate of all death, any MI and any repeat revascularization

Time Frame

30 days, 6 months and 12 months

Secondary Outcome Measure Information:

Title

stent thrombosis

Description

The incidence of stent thrombosis was assessed throughout the follow-up period, according to the conventional ARC (Academic Research Consortium) classification.

Time Frame

30 days. 6 months and 12 months

Title

Non-TVR

Description

Any repeat revascularization of non target vessels

Time Frame

30 days, 6 months and 12 months

Other Pre-specified Outcome Measures:

Title

Composite rate of all death, any MI and any repeat revascularization

Time Frame

30 days, 6 months and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vladimir Ganyukov, MD, PhD

Phone

+79131273905

ganyukov@mail.ru

First Name & Middle Initial & Last Name or Official Title & Degree

Roman Tarasov, MD, PhD

Phone

+79235260446

roman.tarasov@mail.ru

Facility Information:

Facility Name

State Research Institute for Complex Issues of Cardiovascular Diseases

City

Kemerovo

State/Province

Kemerovo Region

ZIP/Postal Code

650002

Country

Russian Federation

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vladimir Ganyukov, MD, PhD

Phone

+79131273905

ganyukov@mail.ru

First Name & Middle Initial & Last Name & Degree

Roman Tarasov, MD, PhD

Phone

+79235260446

roman.tarasov@mail.ru

First Name & Middle Initial & Last Name & Degree

Vladimir Ganyukov, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs