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

STEMI Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02792920
• Other study ID #: XIENCE STEMI Registry
• Status: Recruiting
• Phase: N/A
• First received: March 2, 2016
• Last updated: June 7, 2016
• Start date: March 2016

Study information

• Verified date: June 2016
• Source: Hyogo Brain and Heart Center
• Contact: Yoshinori Yasaka, M.D.
• Phone: +81-79-293-3131
• Email: yoshiysk[@]yahoo.co.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-elevation Acute Myocardial Infarction
• STEMI

Intervention

Device:
• CoCr-EES

Locations

Country	Name	City	State
Japan	Hyogo Brain and Heart Center	Himeji, Hyogo,
Japan	Higashi Takarazuka Sato Hospital	Takarazuka, Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Hyogo Brain and Heart Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	MI (QMI and Non-QMI)		12 months	Yes
Secondary	Any TLR		12 months and 36 months	No
Secondary	Any Target Vessel Revascularization (TVR)		12 months and 36 months	No
Secondary	Death		12 months and 36 months	Yes
Secondary	MACE (Cardiac death, MI and TLR)		12 months and 36 months	Yes
Secondary	Definite or Probable stent thrombosis		12 months and 36 months	Yes