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

June 7, 2016 updated by: Hyogo Brain and Heart Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Himeji, Hyogo,, Japan, 6700981
        • Recruiting
        • Hyogo Brain and Heart Center
        • Contact:
          • Yoshinori Yasaka, M.D.
          • Phone Number: +81-79-293-3131
      • Takarazuka, Hyogo, Japan, 6650873
        • Recruiting
        • Higashi Takarazuka Sato Hospital
        • Contact:
          • Satoru Otsuji, M.D.
          • Phone Number: +81-797-88-2200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with STEMI who are able to undergo CoCr-EES implantation.
  2. Patients with no history of PCI in the target vessel
  3. Patients who are 20 or older at the time of informed consent
  4. Patients who provided written informed consent by himself/herself
  5. Patients who are judged by their treating physician to be able to undergo PCI with CoCr-EES
  6. Patients for whom thrombus aspiration prior to CoCr-EES implantation can be recommended
  7. 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
  8. Patients were obtained finally revascularization of TIMI 3 by visual observation in the target vessel
  9. 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:

  1. 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.
  2. Patients presenting with cardiogenic shock
  3. 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)
  4. Patients with responsible lesion in left main trunk
  5. Patients with renal insufficiency or with chronic renal failure with serum creatinine level of 2.0mg/dL or higher at visit
  6. Patients on hemodialysis
  7. 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.)
  8. Patients who are below the age of 20
  9. Women who were positive in pregnancy test or wish to become pregnant during study duration
  10. Patients who newly developed AMI attributable to the prior stented site
  11. Patients with a known history of allergy to drug, polymer, metal, and other materials used in CoCr-EES
  12. Patients diagnosed with hepatic insufficiency
  13. Patients with target lesion in saphenous vein graft
  14. Patients with active malignant tumor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CoCr-EES
Device: CoCr-EES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hyogo Brain and Heart Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XIENCE STEMI Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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