Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767022
Status:
COMPLETED
Last Update Posted:
2024-06-25
First Post:
2021-02-19
Brief Title:
Compare the Safety and Effectiveness of Genoss DCB and SeQuent Please NEO in Chinese Patients With Coronary ISR
Sponsor:
Genoss Co Ltd
Organization:
Genoss Co Ltd
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Trials to Evaluate the Safety and Effectiveness of Genoss DCB Versus SeQuent Please NEO in Patients With Coronary In-stent Restenosis ISR
Status:
COMPLETED
Status Verified Date:
2024-06
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 purpose of this study is to evaluate the safety and effectiveness of Genoss DCB by demonstrating non-inferiority in patients with in-stent restenosis ISR compared with a product of the same category Sequent Please NEO
The experimental group was treated with Genoss DCB and the control group was treated with SeQuent Please NEO
In this study the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter The safety of the catheter was evaluated by cardiovascular adverse events
The experimental group was treated with Genoss DCB and the control group was treated with SeQuent Please NEO
In this study the end point of 9 months after procedure was used as the main endpoint to evaluate the effectiveness of Paclitaxel coated PTCA balloon catheter The safety of the catheter was evaluated by cardiovascular adverse events
Detailed Description:
In a randomized controlled trials to compare with the same-category medical device Sequent Please NEO 224 patients with in-stent restenosis ISR were recruited from a total of 13 institutions and the enrolled subjects were 1 1 through randomization The ratio was assigned to the test groupGenoss DCB and the control groupSeQuent Please NEO and each of the test or control devices was assigned to receive the procedure
All patients were followed up 30 days 6 months 9 months 1 year and 2 years after procedure and angiographic follow-up was performed 9 months after procedure
All patients were followed up 30 days 6 months 9 months 1 year and 2 years after procedure and angiographic follow-up was performed 9 months after procedure
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