Ignite Creation Date:
2024-05-06 @ 2:20 AM
Last Modification Date:
2024-10-26 @ 11:17 AM
Study NCT ID:
NCT02027870
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2014-01-02
Brief Title:
EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions CREDIT-III
Sponsor:
JW Medical Systems Ltd
Organization:
JW Medical Systems Ltd
Study Overview
Official Title:
A Prospective Multicenter Single-Arm Observational Registry Study to Assess the Safety and Efficacy of EXCEL-II With Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery CREDIT-III Trial
Status:
COMPLETED
Status Verified Date:
2023-04
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:
CREDIT-III
Brief Summary:
The study aims to further assess the safety efficacy and the performance of its delivery system of the new generation Sirolimus-eluting stent of JWMS up to five years
Detailed Description:
1 A prospective a single set multicenter clinical trial
2 The primary in situ in patients with coronary heart disease
3 The center of 28 the actual number of center shall prevailThe plan selected 621 patientswhere the total number of cases in 225 mm specification not less than 30 cases 5 cases each specification of not less than 225 mm
4 Clinical follow-up time points 1 months 6 months 12 months and 18 months of a year and 2 years to 5 years follow-up This test by an independent coronary angiography core laboratories data management and statistical center clinical end points to judge committee and clinical monitoring of all relevant clinical and imaging data collecting sorting statistical analysis and judgementAll the selected patients within five years continuous follow-up tracking phone or outpatient follow-up to observe the happening of adverse events to the forward of the second generation of EXCEL drug-eluting stents des system security to make more accurate and credible evaluation
2 The primary in situ in patients with coronary heart disease
3 The center of 28 the actual number of center shall prevailThe plan selected 621 patientswhere the total number of cases in 225 mm specification not less than 30 cases 5 cases each specification of not less than 225 mm
4 Clinical follow-up time points 1 months 6 months 12 months and 18 months of a year and 2 years to 5 years follow-up This test by an independent coronary angiography core laboratories data management and statistical center clinical end points to judge committee and clinical monitoring of all relevant clinical and imaging data collecting sorting statistical analysis and judgementAll the selected patients within five years continuous follow-up tracking phone or outpatient follow-up to observe the happening of adverse events to the forward of the second generation of EXCEL drug-eluting stents des system security to make more accurate and credible evaluation
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