Back to resultsMulticenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction (XIENCE STEMI)
Primary Purpose
ST-elevation Acute Myocardial Infarction, STEMI
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
CoCr-EES
Sponsored by
About this trial
This is an interventional treatment trial for ST-elevation Acute Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- Hyogo Brain and Heart CenterRecruiting
- Higashi Takarazuka Sato HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CoCr-EES
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
MI (QMI and Non-QMI)
Any TLR
Any Target Vessel Revascularization (TVR)
Death
MACE (Cardiac death, MI and TLR)
Definite or Probable stent thrombosis
Full Information
NCT ID
NCT02792920
First Posted
March 2, 2016
Last Updated
June 7, 2016
Sponsor
Hyogo Brain and Heart Center
1. Study Identification
Unique Protocol Identification Number
NCT02792920
Brief Title
Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction
Acronym
XIENCE STEMI
Official Title
Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hyogo Brain and Heart Center
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Acute Myocardial Infarction, STEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CoCr-EES
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
CoCr-EES
Primary Outcome Measure Information:
Title
Target vessel failure (TVF)
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MI (QMI and Non-QMI)
Time Frame
12 months
Title
Any TLR
Time Frame
12 months and 36 months
Title
Any Target Vessel Revascularization (TVR)
Time Frame
12 months and 36 months
Title
Death
Time Frame
12 months and 36 months
Title
MACE (Cardiac death, MI and TLR)
Time Frame
12 months and 36 months
Title
Definite or Probable stent thrombosis
Time Frame
12 months and 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoshinori Yasaka, M.D.
Phone
+81-79-293-3131
Email
yoshiysk@yahoo.co.jp
Facility Information:
Facility Name
Hyogo Brain and Heart Center
City
Himeji, Hyogo,
ZIP/Postal Code
6700981
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshinori Yasaka, M.D.
Phone
+81-79-293-3131
Facility Name
Higashi Takarazuka Sato Hospital
City
Takarazuka, Hyogo
ZIP/Postal Code
6650873
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoru Otsuji, M.D.
Phone
+81-797-88-2200
12. IPD Sharing Statement
Learn more about this trial
Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction
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