China Made Sirolimus Eluting Stent for Intermediate Lesion
SESIL
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 coronary-artery-disease
Started May 2009
Typical duration for phase_2 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJune 17, 2011
April 1, 2009
2.4 years
April 1, 2011
June 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
major adverse cardiac events
12 months
Study Arms (2)
SES
EXPERIMENTALincluding 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).
medicine
OTHERInterventions
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).
Eligibility Criteria
You may qualify if:
- age 18-80 years old
- both gender
- native coronary lesion
- narrowing 50-70%
- vessel size 2.5-4.0 in diameter
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ruijin hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 1, 2011
First Posted
June 17, 2011
Study Start
May 1, 2009
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
June 17, 2011
Record last verified: 2009-04