A Phase 4 interventional study of helios stent in Coronary Artery Disease, sponsored by Kinhely Bio-tech Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by Kinhely Bio-tech Co., Ltd. · Phase 4, Interventional, and Treatment
research topic:helios After registration of clinical research bidders:kinhely bio-tech Co.Ltd study design:A prospective single treatment group multicenter clinical study Number of patients:Included in the subjects of 800 cases Main research purpose:Evaluation of safety and effectiveness Mainly studies the finish:1 year target lesion of the failure
Inclusion criteria :
one:Gender not limited at the age of 18 to 80 two:myocardial ischemia or angina symptoms of coronary artery disease three:A narrow is less than 50% treated with stents four:Comply with the instructions five:Voluntarily signed the informed consent form exclusion criteria: one:Pregnant women two:cardiac shock three:Against a suppository medicines or allergies four:Participated in other test research in the first 6 months five:Within 6 months after PCI plans to accept non cardiac surgery six:Non-compliant patient Follow-up time:A month for 6 months and 9 months to 1 year to 2 years follow-up progress plan:All center within 6 months after start of complete into the group
no desired
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 800 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →This is the only study on the registry with Kinhely Bio-tech Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the group with helios stent implanted
Device: helios stent
the group with helios stent implanted
1 year incidence of target lesion
Target blood vessels caused by cardiac death and myocardial infarction and ischemia driven overall incidence of target lesion revascularization
Time frame: 1year
cardiac death Target blood vessels caused by myocardial infarction Ischemia driven target lesion revascularization of 1 year and 2 years,MACE, Stent thrombosis events,clinical success.
Death and myocardial infarction and thromboembolism events and hospitalizations and the incidence of major adverse cardiac events as the standard for safety evaluation
Time frame: 2 years
2 years, the incidence of various combination of the pathological changes of failure
Cardiac death drive target blood vessels lead to myocardial infarction and ischemia of the incidence of target lesion revascularization
Time frame: 2 years
Rehospitalization rate
Stent placement in patients with the incidence of hospitalized again
Time frame: 2 years
This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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