NCT01781715

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

2.3 years

First QC Date

January 29, 2013

Last Update Submit

January 30, 2013

Conditions

ST Elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

  • All death including cardiac and non cardiac death

    30 days, 6 months and 12 montrhs

  • Recurrent MI

    30 days, 6 months and 12 months

  • Any revascularizations (TLR or TVR)

    30 days, 6 months and 12 months

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

    30 days, 6 months and 12 months

Secondary Outcomes (2)

  • stent thrombosis

    30 days. 6 months and 12 months

  • Non-TVR

    30 days, 6 months and 12 months

Other Outcomes (1)

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

    30 days, 6 months and 12 months

Study Arms (2)

Multivessel stenting

EXPERIMENTAL

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

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)

Device: Zotarolimus-eluting coronary stent

Interventions

Zotarolimus-eluting coronary stentDEVICE

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

Also known as: Resolute Integrity stent
Multivessel stentingStaged revascularization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Institute for Complex Issues of Cardiovascular Diseases

Kemerovo, Kemerovo Oblast, 650002, Russia

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Vladimir Ganyukov, MD, PhD

CONTACT

+79131273905ganyukov@mail.ru

Roman Tarasov, MD, PhD

CONTACT

+79235260446roman.tarasov@mail.ru

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 29, 2013

First Posted

February 1, 2013

Study Start

September 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

RU(1)