Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600997
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-14
Brief Title:
Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers a Multicenter Randomized TrialPARAT-MT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers a Multicenter Randomized TrialPARAT-MT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective multicenter randomized controlled clinical trial with open-label treatment and blinded endpoint assessment
Detailed Description:
The PARAT-MT is to evaluate whether small unruptured cerebral aneurusm patients treated with FD superior to those treated with conventional endovascular therapy It is a prospective multicenter randomized controlled clinical trial with open-label treatment and blinded endpoint assessment trial
Primary Outcome Endpoint A composite endpoint of major recurrence any stroke or death at one year post-surgery
Second Outcome Endpoint
1 All-cause mortality at 12 months post-surgery
2 Any stroke at 12 months post-surgery
3 Major recurrence rate at 12 months post-surgery
4 Transient ischemic attack TIA occurrence rate at 12 months post-surgery
5 Periprocedural 30-day procedure-related complications rate
6 Ipsilateral stroke or neurologic death at 1 month and 12 months post-surgery
7 Severe disability rate at 1 month and 12 months post-surgery mRS 2
8 Complete aneurysm occlusion rate at 12 months post-surgery Raymond I
9 The rate of in-stent stenosis 50 at 12 months post-surgery
10 Technical success rate
11 Target parent artery retreatment rate at 12 months post-surgery
12 Target aneurysm retreatment rate at 12 months post-surgery
Primary Outcome Endpoint A composite endpoint of major recurrence any stroke or death at one year post-surgery
Second Outcome Endpoint
1 All-cause mortality at 12 months post-surgery
2 Any stroke at 12 months post-surgery
3 Major recurrence rate at 12 months post-surgery
4 Transient ischemic attack TIA occurrence rate at 12 months post-surgery
5 Periprocedural 30-day procedure-related complications rate
6 Ipsilateral stroke or neurologic death at 1 month and 12 months post-surgery
7 Severe disability rate at 1 month and 12 months post-surgery mRS 2
8 Complete aneurysm occlusion rate at 12 months post-surgery Raymond I
9 The rate of in-stent stenosis 50 at 12 months post-surgery
10 Technical success rate
11 Target parent artery retreatment rate at 12 months post-surgery
12 Target aneurysm retreatment rate at 12 months post-surgery
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