Coronary Artery Disease Clinical Trial
Official title:
A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer Sirolimus-eluting Stent Safety and Effectiveness in Treatment of Coronary Artery Disease
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 ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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