Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03716011
Status:
NOT_YET_RECRUITING
Last Update Posted:
2018-10-23
First Post:
2018-10-17
Brief Title:
A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
Sponsor:
JW Medical Systems Ltd
Organization:
JW Medical Systems Ltd
Study Overview
Official Title:
A Large Prospective Randomized Multicenter Clinical Study Evaluating the Safety and Efficacy of the Post-marketing Drug-eluting Stent System Rapamycin - the EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2018-10
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:
1 Prospective randomized multicenter clinical study
2 This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways Adopting non - inferiority design 2700 cases were enrolled
3 EDC system eCRF electronic data collection system
4 Follow-up points 30 days3 months 12 months 24 months 36 months 48 months and 60 months after the operation
2 This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways Adopting non - inferiority design 2700 cases were enrolled
3 EDC system eCRF electronic data collection system
4 Follow-up points 30 days3 months 12 months 24 months 36 months 48 months and 60 months after the operation
Detailed Description:
1 Subjects are eligible for coronary intervention
2 The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations
3 The selection of target vessel is based on the criteria of a diameter between 225mm and 40mm
4 If a stent needs to be placed at the target vessel it is recommended that there be at least 2mm overlap between the stents if the stent expansion is not sufficient post-dilatation treatment is required
2 The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations
3 The selection of target vessel is based on the criteria of a diameter between 225mm and 40mm
4 If a stent needs to be placed at the target vessel it is recommended that there be at least 2mm overlap between the stents if the stent expansion is not sufficient post-dilatation treatment is required
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None