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Clinical Trials/NCT02792920
NCT02792920UnknownNot Applicable

Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction

Hyogo Brain and Heart Center2 sites in 1 country400 target enrollmentStarted: March 1, 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
400
Locations
2
Primary Endpoint
Target vessel failure (TVF)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 who meet all the following vascular inclusion criteria i.Patients with target lesion in native coronary artery ii.Patients with visual maximum vessel diameter of the target stent site in target lesion
  • •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.

Exclusion Criteria

  • •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

Arms & Interventions

CoCr-EES

Other

Intervention: CoCr-EES (Device)

Outcomes

Primary Outcomes

Target vessel failure (TVF)

Time Frame: 12 months

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)

Secondary Outcomes

  • Any TLR(12 months and 36 months)
  • Any Target Vessel Revascularization (TVR)(12 months and 36 months)
  • MI (QMI and Non-QMI)(12 months)
  • Death(12 months and 36 months)
  • MACE (Cardiac death, MI and TLR)(12 months and 36 months)
  • Definite or Probable stent thrombosis(12 months and 36 months)

Investigators

Sponsor
Hyogo Brain and Heart Center
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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