China Made Sirolimus Eluting Stent for Intermediate Lesion

China Made Sirolimus Eluting Stent for Treatment of Coronary Intermediate Lesion

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01375296

Acronym

SESIL

Enrollment

600

Registered

2011-06-17

Start date

2009-05-31

Completion date

2011-11-30

Last updated

2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief 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.

Interventions

DEVICEChina-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).

OTHERroutine medicine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
target vessel failure	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 \[PTCA\]).

Secondary

Measure	Time frame	Description
major adverse cardiac events	12 months	including cardiac death, re-infarction and target vessel revascularization.

Countries

China

Contacts

Primary ContactRuiyan Zhang, MD

zhangruiyan@263.net862164370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026