China Made Sirolimus Eluting Stent for Intermediate Lesion (SESIL)

Shanghai Jiao Tong University School of Medicine

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Coronary Artery Disease

Treatments: Other: routine medicine; Device: China-made SES (Firebird 2 and Excel)

Study type: Interventional

Funder types: Other

Identifiers

NCT01375296

RJH20100918

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

SES

Experimental group

Description:

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).

Treatment:

Device: China-made SES (Firebird 2 and Excel)

medicine

Other group

Treatment:

Other: routine medicine