Clinical trial NCT02792920: Multicenter Registry of Very Early and Late Clinical Outcomes to Everolimus-eluting Cobalt-Chromium Stent In Patients With ST Elevation Myocardial Infarction
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
Overall status: UNKNOWN
Phase: NA
Conditions: ST-elevation Acute Myocardial Infarction
STEMI
Lead sponsor: Hyogo Brain and Heart Center
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 12 months
Secondary outcomes:
measure: MI (QMI and Non-QMI)
timeFrame: 12 months
measure: Any TLR
timeFrame: 12 months and 36 months
measure: Any Target Vessel Revascularization (TVR)
timeFrame: 12 months and 36 months
measure: Death
timeFrame: 12 months and 36 months
measure: MACE (Cardiac death, MI and TLR)
timeFrame: 12 months and 36 months
measure: Definite or Probable stent thrombosis
timeFrame: 12 months and 36 months
Other outcomes:
Locations:
city: Himeji, Hyogo,
country: Japan
facility: Hyogo Brain and Heart Center
city: Takarazuka, Hyogo
country: Japan
facility: Higashi Takarazuka Sato Hospital
Study officials:
References: