China Made Sirolimus Eluting Stent for Intermediate Lesion (SESIL)
|ClinicalTrials.gov Identifier: NCT01375296|
Recruitment Status : Unknown
Verified April 2009 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : June 17, 2011
Last Update Posted : June 17, 2011
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: China-made SES (Firebird 2 and Excel) Other: routine medicine||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||November 2011|
including two types of China-made SES, i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).
Device: China-made SES (Firebird 2 and Excel)
patients with coronary 50-70% narrowing treated with China-made SES stent,i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).
Other: routine medicine
patients with coronary 50-70% narrowing treated with routine medicine
- target vessel failure [ Time Frame: 12 months ]defined as the occurrence of any of the following within 12 months after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularization of the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]).
- major adverse cardiac events [ Time Frame: 12 months ]including cardiac death, re-infarction and target vessel revascularization.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375296
|Contact: Ruiyan Zhang, MD||862164370045 ext email@example.com|
|ruijin hospital, Shanghai Jiao Tong University, School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Ruiyan Zhang, MD 862164370045 ext 665215 firstname.lastname@example.org|