China Made Sirolimus Eluting Stent for Intermediate Lesion

Coronary Artery Disease Clinical Trial

— SESIL  

Official title:

China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01375296
• Other study ID #: RJH20100918
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: April 1, 2011
• Last updated: June 16, 2011
• Start date: May 2009
• Est. completion date: November 2011

Study information

• Verified date: April 2009
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Ruiyan Zhang, MD
• Phone: 862164370045
• Email: zhangruiyan[@]263.net
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Sirolimus-eluting stent (SES) has been proven to improve outcomes in patients with significant coronary artery diseae(> 70% lumen diameter narrowing). But, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of SES in these patients remains unclear. Here the investigators hypothesize that application of China-made SES may improve the clinical outcomes in these setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 18-80 years old

• both gender

• native coronary lesion

• narrowing 50-70%

• vessel size 2.5-4.0 in diameter

Exclusion Criteria:

• without informed consent,

• ST elevation myocardial infarction within 7 days,

• left main lesion,

• by-pass graft,

• restenosis

• abnormal liver function before randomization,

• active hepatitis or muscular disease,

• impaired renal function with serum creatinine level > 3mg/dl ,

• impaired left ventricular function with LVEF < 30%,

• participate in other studies.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	ruijin hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target vessel failure	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]).	12 months	Yes
Secondary	major adverse cardiac events	including cardiac death, re-infarction and target vessel revascularization.	12 months	Yes