Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01880879
Status:
UNKNOWN
Last Update Posted:
2013-06-24
First Post:
2013-05-30
Brief Title:
A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer SES Safety and Effectiveness in CAD Treatment
Sponsor:
Kinhely Bio-tech Co Ltd
Organization:
Kinhely Bio-tech Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Trial Evaluating Helios Biodegradable Polymer Sirolimus-eluting Stent Safety and Effectiveness in Treatment of Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2013-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pro-HOPE
Brief Summary:
research topichelios After registration of clinical research bidderskinhely bio-tech CoLtd study designA prospective single treatment group multicenter clinical study Number of patientsIncluded in the subjects of 800 cases Main research purposeEvaluation of safety and effectiveness Mainly studies the finish1 year target lesion of the failure
Inclusion criteria
oneGender not limited at the age of 18 to 80 twomyocardial ischemia or angina symptoms of coronary artery disease threeA narrow is less than 50 treated with stents fourComply with the instructions fiveVoluntarily signed the informed consent form exclusion criteria onePregnant women twocardiac shock threeAgainst a suppository medicines or allergies fourParticipated in other test research in the first 6 months fiveWithin 6 months after PCI plans to accept non cardiac surgery sixNon-compliant patient Follow-up timeA month for 6 months and 9 months to 1 year to 2 years follow-up progress planAll center within 6 months after start of complete into the group
Inclusion criteria
oneGender not limited at the age of 18 to 80 twomyocardial ischemia or angina symptoms of coronary artery disease threeA narrow is less than 50 treated with stents fourComply with the instructions fiveVoluntarily signed the informed consent form exclusion criteria onePregnant women twocardiac shock threeAgainst a suppository medicines or allergies fourParticipated in other test research in the first 6 months fiveWithin 6 months after PCI plans to accept non cardiac surgery sixNon-compliant patient Follow-up timeA month for 6 months and 9 months to 1 year to 2 years follow-up progress planAll center within 6 months after start of complete into the group
Detailed Description:
no desired
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None