NCT06600997

Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers: a Multicenter Randomized Trial(PARAT-MT)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,008 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Cerebral Aneurysm Unruptured
• Cerebral Aneurysm

Interventions

Type	Name	Description
DEVICE	Flow Diversion for Endovascular Treatment of Intracranial Aneurysms	Flow Diversion for Endovascular Treatment of Intracranial Aneurysms
DEVICE	Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms	Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-10-30
• Completion: 2031-10-30
• First posted: 2024-09-19
• Last updated: 2025-01-03