NCT02792920

Brief Summary

To compare early and late clinical outcomes with everolimus-eluting cobalt-chromium stent in patients with ST-elevation acute myocardial infarction, as well as identify the characteristics and efficacy of CoCr-EES. Also, OCT sub-analysis will be conducted

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

March 2, 2016

Last Update Submit

June 7, 2016

Conditions

ST-elevation Acute Myocardial InfarctionSTEMI

Outcome Measures

Primary Outcomes (1)

  • Target vessel failure (TVF)

    Target vessel failure (TVF) at 12 months after CoCr-EES implantation. TVF consists of defined as cardiac death, target vessel-related recurrent myocardial infarction (MI) or Target Lesion Revascularization (TLR)

    12 months

Secondary Outcomes (6)

  • MI (QMI and Non-QMI)

    12 months

  • Any TLR

    12 months and 36 months

  • Any Target Vessel Revascularization (TVR)

    12 months and 36 months

  • Death

    12 months and 36 months

  • MACE (Cardiac death, MI and TLR)

    12 months and 36 months

  • +1 more secondary outcomes

Study Arms (1)

CoCr-EES

OTHER
Device: CoCr-EES

Interventions

CoCr-EESDEVICE
CoCr-EES

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with STEMI who are able to undergo CoCr-EES implantation.
  • Patients with no history of PCI in the target vessel
  • Patients who are 20 or older at the time of informed consent
  • Patients who provided written informed consent by himself/herself
  • Patients who are judged by their treating physician to be able to undergo PCI with CoCr-EES
  • Patients for whom thrombus aspiration prior to CoCr-EES implantation can be recommended
  • Patients were obtained finally revascularization of TIMI 3 by visual observation in the target vessel
  • Patients who are able to treat with CoCr-EES the diameter 2.5mm or more and 3.5mm or less and the length of 8mm or more and 28mm or less.

You may not qualify if:

  • Patients participating in the other ongoing registry or clinical study(except post-marketing surveillance of CoCr-EES), or receiving treatment which may impact on endpoints of this study.
  • Patients presenting with cardiogenic shock
  • Patients for whom 12-month and 36-month CAG and clinical follow up is considered difficult (patient's residence should also be taken into account)
  • Patients with responsible lesion in left main trunk
  • Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit
  • Patients on hemodialysis
  • Patients with a known history of adverse drug reactions to aspirin, or clopidogrel or prasugrel (This may not apply if safety of ticlopidine is confirmed as an alternative drug.)
  • Patients who are below the age of 20
  • Women who were positive in pregnancy test or wish to become pregnant during study duration
  • Patients who newly developed AMI attributable to the prior stented site
  • Patients with a known history of allergy to drug, polymer, metal, and other materials used in CoCr-EES
  • Patients diagnosed with hepatic insufficiency
  • Patients with target lesion in saphenous vein graft
  • Patients with active malignant tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hyogo Brain and Heart Center

Himeji, Hyogo,, 6700981, Japan

RECRUITING

Higashi Takarazuka Sato Hospital

Takarazuka, Hyogo, 6650873, Japan

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

Yoshinori Yasaka, M.D.

CONTACT

+81-79-293-3131yoshiysk@yahoo.co.jp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

June 8, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Last Updated

June 8, 2016

Record last verified: 2016-06

Locations

JP(2)