A prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment.
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. Incidence of hemorrhagic stroke at 12 months post-surgery. 11. Technical success rate. 12. Target parent artery retreatment rate at 12 months post-surgery. 13. Target aneurysm retreatment rate at 12 months post-surgery. 14. Surgical operation time. 15. Radiation dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,008
Flow Diversion for Endovascular Treatment of Intracranial Aneurysms
Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms
Major recurrence, any stroke or death
A composite endpoint of major recurrence, any stroke or death
Time frame: At 1 year post-surgery
All-cause mortality
All-cause mortality
Time frame: At 12 months post-surgery
Any stroke
Any stroke
Time frame: At 12 months post-surgery
Major recurrence
Major recurrence
Time frame: At 12 months post-surgery
Transient ischemic attack (TIA)
Transient ischemic attack (TIA)
Time frame: At 12 months post-surgery
Procedure-related complications
Procedure-related complications
Time frame: Periprocedural (30 days)
Ipsilateral stroke or neurologic death
Ipsilateral stroke or neurologic death
Time frame: At 1 month and 12 months post-surgery
Severe disability
Severe disability (mRS \> 2)
Time frame: At 1 month and 12 months post-surgery
Complete aneurysm occlusion
Complete aneurysm occlusion (Raymond I)
Time frame: at 12 months post-surgery
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The rate of in-stent stenosis ≥50%
The rate of in-stent stenosis ≥50%
Time frame: At 12 months post-surgery
hemorrhagic stroke
Incidence of hemorrhagic stroke
Time frame: at 12 months post-surgery
Technical success rate
Technical success rate
Time frame: 24 hours after endovascular treatment
Target parent artery retreatment rate
Target parent artery retreatment rate
Time frame: At 12 months post-surgery
Target aneurysm retreatment rate
Target aneurysm retreatment rate
Time frame: At 12 months post-surgery
Surgical operation time
Surgical operation time
Time frame: during surgery
Radiation dose
Radiation dose
Time frame: during surgery