Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02747329
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2016-04-18
Brief Title:
A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT
Sponsor:
Sino Medical Sciences Technology Inc
Organization:
Sino Medical Sciences Technology Inc
Study Overview
Official Title:
A Prospective Multicenter Randomized Comparative Evaluation of BuMA Supreme Stent and of Xience Stent in Terms of the Extent of Neointimal Formation at 1 Month and 2 Months Via OCT After Implantation in High Bleeding Risk CAD PatientsPIONEER-II OCT Study
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
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:
None
Brief Summary:
The objective of this study is a comparative evaluation of BuMA Supreme stent and of Xience VPrime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients with coronary artery disease using OCT
Detailed Description:
This is a prospective multicenter randomized non-inferiority study which will enroll a total of 80 subjects from approximately 8 centers All subjects will be firstly randomly assigned to 1st month OCT 40 pts or 2nd month OCT group40 pts Then both two groups will be randomly assigned to undergoing implantation of BuMA Supreme stent 20 pts or Xience VPrime stent 20 pts If non-inferiority was met superiority test will be planned
All of the patients be followed up to 2 years The follow-up visits will be conducted at 1 or 2 months including QCAOCT investigation 3 months 6 months 1 and 2 years post percutaneous coronary interventionPCIin order to observe the Primary Endpoint and Secondary Endpoints
All of the patients be followed up to 2 years The follow-up visits will be conducted at 1 or 2 months including QCAOCT investigation 3 months 6 months 1 and 2 years post percutaneous coronary interventionPCIin order to observe the Primary Endpoint and Secondary Endpoints
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