Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733443
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2021-01-25
Brief Title:
The Safety and Efficacy of Biolimus in the Treatment of Patients With in Stent Restenosis
Sponsor:
JW Medical Systems Ltd
Organization:
JW Medical Systems Ltd
Study Overview
Official Title:
A Prospective Multicenter Non-inferior Randomized Controlled Clinical Trial Comparing the Safety and Efficacy of Sequent Please Neo With Biolimus-released Coronary Balloon Catheter in the Treatment of Coronary Stent Restenosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
This study consisted of a randomized controlled trial group and a long balloon observation group
In the randomized control group 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 11 ratio 30 consecutive subjects will be enrolled in the long balloon observation group using graceful molimus release coronary balloon catheter with length of 45mm All 310 subjects were followed up at baseline surgery discharge 1 month after surgery 6 months after surgery 9 months after surgery 1 2 and 3 years after surgery and angiography was performed at 9 months after surgery
In the randomized control group 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 11 ratio 30 consecutive subjects will be enrolled in the long balloon observation group using graceful molimus release coronary balloon catheter with length of 45mm All 310 subjects were followed up at baseline surgery discharge 1 month after surgery 6 months after surgery 9 months after surgery 1 2 and 3 years after surgery and angiography was performed at 9 months after surgery
Detailed Description:
This study consisted of a randomized controlled trial group and a long balloon observation group
In the randomized control group 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 11 ratio 30 consecutive subjects will be enrolled in the long balloon observation group using graceful molimus release coronary balloon catheter with length of 45mm All 310 subjects were followed up at baseline surgery discharge 1 month after surgery 6 months after surgery 9 months after surgery 1 2 and 3 years after surgery and angiography was performed at 9 months after surgery
The primary endpoint was late lumen loss at 9 months
The study will enroll 310 subjects The sample size determination process is as follows
Randomized controlled trial group
A prospective multicenter randomized controlled non-inferior clinical trial design was used with the primary endpoint of intrasegonal LLL at 9 months postoperatively Sample size was calculated according to the following assumptions
1 According to previous clinical studies the LLL of the segment 9 months after paclitaxel release coronary catheter Sequent Please was 046048mm1 and 046051mm2 2 In this study it was estimated that the mean LLL in the lesion segment of the experimental group and the control group 9 months after surgery was 046mm and the standard deviation was 050mm 3 The clinically acceptable non-infertility threshold was 0195mm When the significance level of the statistical test was set as one-sided 25 and the assurance level was set as 80 they were randomly divided into groups at a ratio of 11 4 Considering the abscission rate of 25 at the same time considering the early withdrawal from the group caused by other reasons and the random setting 280 patients were finally enrolled including 140 in the experimental group and 140 in the control group
Long balloon observation group
Because the maximum length of Sequent Please Neo in the control group was 40mm subjects suitable for 45mm long balloon could not be randomly enrolled in the randomized controlled trial group Therefore this observation group was selected with a sample size of 30 cases
In the randomized control group 280 subjects with in-stent restenosis were planned to be recruited and randomly assigned to the test group and the control group in a 11 ratio 30 consecutive subjects will be enrolled in the long balloon observation group using graceful molimus release coronary balloon catheter with length of 45mm All 310 subjects were followed up at baseline surgery discharge 1 month after surgery 6 months after surgery 9 months after surgery 1 2 and 3 years after surgery and angiography was performed at 9 months after surgery
The primary endpoint was late lumen loss at 9 months
The study will enroll 310 subjects The sample size determination process is as follows
Randomized controlled trial group
A prospective multicenter randomized controlled non-inferior clinical trial design was used with the primary endpoint of intrasegonal LLL at 9 months postoperatively Sample size was calculated according to the following assumptions
1 According to previous clinical studies the LLL of the segment 9 months after paclitaxel release coronary catheter Sequent Please was 046048mm1 and 046051mm2 2 In this study it was estimated that the mean LLL in the lesion segment of the experimental group and the control group 9 months after surgery was 046mm and the standard deviation was 050mm 3 The clinically acceptable non-infertility threshold was 0195mm When the significance level of the statistical test was set as one-sided 25 and the assurance level was set as 80 they were randomly divided into groups at a ratio of 11 4 Considering the abscission rate of 25 at the same time considering the early withdrawal from the group caused by other reasons and the random setting 280 patients were finally enrolled including 140 in the experimental group and 140 in the control group
Long balloon observation group
Because the maximum length of Sequent Please Neo in the control group was 40mm subjects suitable for 45mm long balloon could not be randomly enrolled in the randomized controlled trial group Therefore this observation group was selected with a sample size of 30 cases
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