Status:
UNKNOWN
A Study to Evaluate Safety and Efficacy of the ExcelTM Sirolimus Eluting Stent With a Biodegradable Polymer Versus Sirolimus Eluting Stent With Non-Biodegradable Polymer in the Treatment of Patients With de Novo Coronary Artery Lesions
Lead Sponsor:
JW Medical Systems Ltd
Conditions:
Ischemia
Cardiac Death
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
E.V.O.L.U.T.I.O.N.: A Randomized Study to Evaluate Safety and Efficacy of the Excel Sirolimus Eluting Stent with a Biodegradable Polymer Versus Sirolimus Eluting Stent with a Non-Biodegradable Polymer...
Detailed Description
E.V.O.L.U.T.I.O.N.: A Randomized Study to Evaluate Safety and Efficacy of the Excel Sirolimus Eluting Stent with a Biodegradable Polymer Versus Sirolimus Eluting Stent with a Non-Biodegradable Polymer...
Eligibility Criteria
Inclusion
- Patient \> 18 years of age.
- Diagnosis of stable angina, unstable angina or silent ischemia (evidence of myocardial ischemia).
- Positive functional study or reversible change in the electrocardiogram (ECG) consistent with ischemia.
- Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Patient must agree to undergo all required follow-up exam- inations.
- Angiographic
- Presence of one or more de novo coronary artery stenosis \> 50% in native coronary arteries that corresponds with the evidence of ischemia. NOTE: In the presence of multiple de novo coronary lesions a maximum of four (4) planned Excel or Cypher stents may be used.
- The target lesion(s) must be \< 24mm in length and the reference diameter is \> 2.5 mm and \< 3.75 mm (visual estimate).
Exclusion
- Patient is pregnant or breast feeding.
- Patient is allergic or has a contraindication to aspirin, clopidogrel and ticlopidine, heparin and bivalirudin, stainless steel, PLA, contrast media (that can not be adequately pre- medicated), and sirolimus (or its analogues).
- Patient has evidence of an Acute Myocardial Infarction evidenced by elevation of CK/CK-MB or Troponin per clinical site standards, within 72 hours of the index procedure.
- Patient is unable to provide informed consent.
- Patient is participating in another device or drug study that has not reached the primary endpoint of the study.
- Patient is considered for a DES other than the Excel or the Cypher stents.
- Patient has a co-morbid condition(s) that could limit the patient's ability to participate in the study, comply with follow- up requirements and impact the scientific integrity of the study.
- Angiographic
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
1944 Patients enrolled
Trial Details
Trial ID
NCT00825773
Start Date
October 1 2008
End Date
April 1 2014
Last Update
January 26 2009
Active Locations (1)
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1
JW Medical Systems
Beijing, China, 100037