Status:
UNKNOWN
Safety and Efficacy Study of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction (STEMI) and Analysis of Current Status of Emergency PCI Green Channel for STEMI Patients in China
Lead Sponsor:
Beijing Chao Yang Hospital
Conditions:
Myocardial Infarction
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients with acute ST elevation myocardial infarction. It also aims to analyze the current status of emergency PCI...
Eligibility Criteria
Inclusion
- The patient must be ≥18 years and ≤75 of age.
- Prolonged, continuous (≥ 30 min) chest pain despite nitrate and: (1) ST-segment elevation ≥ at least 2 leads, with reciprocal ST-segment elevation ≥ 0.05mv and precordial leads ST-segment elevation ≥ 0.01mv, or (2) newly developed left bundle branch block
- Symptoms ≥ 30 min and ≤12 hours
- The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form"
- All lesions requiring interventions in one or more native coronary arteries are amendable for implantation of one or more Cypher® Sirolimus-Eluting Coronary Stent System or Endeavor® Zotarolimus-Eluting Coronary Stent
- The patient or guardian is willing and able to cooperate with study procedures and required follow up visits.
Exclusion
- Pregnant and breast-feeding female and female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
- Systemic (intravenous) Sirolimus use within 12 months.
- Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current platelet count \<100 x 10\^9cells/L or Hgb \<10 g/dL.
- Fibrinolytic therapy for current MI treatment
- Previous coronary intervention on target vessel or post-CABG vessel disease
- Transplant patients
- Patients with EF\<25%
- Patients with cardiogenic shock; with a life expectancy shorter than 12 months
- Severe kidney dysfunction: Creatinine level ≥2.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT ≥ 3 times upper normal reference values).
- The patient is currently, and during the CREST-MI Study, participating in another investigational device or drug study that clinically interferes with the CREST-MI study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the CREST-MI Study once.
- Severe tortuous or calcified vessel; stent can not or has difficulty to go through; blood vessel diameter is smaller than the minimum stent diameter available; patients unsuitable for stent implantation.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
1020 Patients enrolled
Trial Details
Trial ID
NCT00781716
Start Date
October 1 2008
End Date
May 1 2011
Last Update
October 29 2008
Active Locations (1)
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1
Beijing Chaoyang Hospital Heart Center
Beijing, BJ, China, 10000