Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-06 @ 3:19 PM
Study NCT ID:
NCT01909869
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2013-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot First In Man Study of EXCEL-Ⅱto Treat the Patients With de Novo Coronary Artery Lesions
Sponsor:
JW Medical Systems Ltd
Organization:
Study Overview
Official Title:
A PILOT First-In-Man Study to Evaluate Safety and Efficacy of the EXCEL-Ⅱ With Cobalt Chromium Alloys Sirolimus Eluting Biodegradable Polymer Stent in the Treatment of Patients With de Novo Coronary Artery Lesions(CREDIT-I)
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
Brief Summary:
One of the purpose of this study is to assess the preliminary safety and feasibility,and to provide related information and evidence for the design of the further pivotal randomized control trial.the other purpose is to assess the performace of the stent delivery system.
Detailed Description:
1. Single-center, prospective, pilot study
2. De novo,coronary artery, single vessel and single lesion
3. Sample size = 45
4. Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years
5. Randomization 2:1 Angio and OCT scheduled follow-up in the hospital
6. Follow-up Angio and OCT randomized 30 patients for 4-month and 15 patiens for 12-month
2. De novo,coronary artery, single vessel and single lesion
3. Sample size = 45
4. Follow- up clinical or phone at 1-month,9-month and annually 2 to 5 years
5. Randomization 2:1 Angio and OCT scheduled follow-up in the hospital
6. Follow-up Angio and OCT randomized 30 patients for 4-month and 15 patiens for 12-month
Study Oversight
Has Oversight DMC:
True
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?: