China Made Sirolimus Eluting Stent for Intermediate Lesion

Shanghai Jiao Tong University School of Medicine600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Coronary Artery Disease

Interventions

China-made SES (Firebird 2 and Excel)DEVICE

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).

routine medicineOTHER

patients with coronary 50-70% narrowing treated with routine medicine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

ruijin hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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 \[PTCA\]).

Time frame: 12 months

Secondary Outcomes

major adverse cardiac events

including cardiac death, re-infarction and target vessel revascularization.

Time frame: 12 months

Central Contacts

Ruiyan Zhang, MD

CONTACT

862164370045 zhangruiyan@263.net

Data from ClinicalTrials.gov

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