Cerebral Aneurysm, Cerebral Aneurysm Unruptured
Conditions
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. 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.
Interventions
DEVICEFlow Diversion for Endovascular Treatment of Intracranial Aneurysms
Flow Diversion for Endovascular Treatment of Intracranial Aneurysms
DEVICEConventional 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
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years. 2. Previously unruptured saccular cerebral aneurysm arising from intradural segments of the internal carotid artery and intracranial segments of the vertebral artery. 3. Measuring ≤10mm in maximum diameter 4. Subjects capable of understanding the study's purpose, willing to participate, and have signed an informed consent form.
Exclusion criteria
1. Subjects with two or more multiple aneurysms requiring treatment within one year. 2. Subjects with arteriovenous malformations or moyamoya disease. 3. Subjects with ruptured, recurrent, or dissecting aneurysms. 4. Subjects with symptomatic cerebral stenosis \>70%; 5. Subjects who have experienced a stroke (cerebral hemorrhage, cerebral infarction) within the past month. 6. Clinical condition is extremely poor with a modified Rankin score of ≥3. 7. Subjects planned for surgical/interventional procedures within three months. 8. Subjects deemed inappropriate for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficult stent delivery, etc.). 9. Subjects with severe comorbidities, unsuitable for anesthesia or endovascular surgery (e.g., major cardiac, pulmonary, hepatic, splenic, renal diseases, atrial fibrillation ,brain tumors, severe active infections, disseminated intravascular coagulation, history of severe mental illness). 10. Subjects unable to tolerate antiplatelet or anticoagulant therapy. 11. Subjects who has had or are likely to have a severe reaction to contrast media. 12. Subjects with a history of allergy to nickel-titanium, cobalt-chromium, or platinum-tungsten alloys. 13. Subjects who have participated in other drug or medical device clinical trials and have not reached the primary endpoint time limit. 14. Pregnant or breastfeeding women. 15. Subjects with an expected lifespan of less than 12 months. 16. Subjects deemed by the investigator to have poor compliance, unable to complete the study as required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major recurrence, any stroke or death | At 1 year post-surgery | A composite endpoint of major recurrence, any stroke or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any stroke | At 12 months post-surgery | Any stroke |
| Major recurrence | At 12 months post-surgery | Major recurrence |
| Transient ischemic attack (TIA) | At 12 months post-surgery | Transient ischemic attack (TIA) |
| Procedure-related complications | Periprocedural (30 days) | Procedure-related complications |
| Ipsilateral stroke or neurologic death | At 1 month and 12 months post-surgery | Ipsilateral stroke or neurologic death |
| Severe disability | At 1 month and 12 months post-surgery | Severe disability (mRS \> 2) |
| Complete aneurysm occlusion | at 12 months post-surgery | Complete aneurysm occlusion (Raymond I) |
| All-cause mortality | At 12 months post-surgery | All-cause mortality |
| hemorrhagic stroke | at 12 months post-surgery | Incidence of hemorrhagic stroke |
| Technical success rate | 24 hours after endovascular treatment | Technical success rate |
| Target parent artery retreatment rate | At 12 months post-surgery | Target parent artery retreatment rate |
| Target aneurysm retreatment rate | At 12 months post-surgery | Target aneurysm retreatment rate |
| Surgical operation time | during surgery | Surgical operation time |
| Radiation dose | during surgery | Radiation dose |
| The rate of in-stent stenosis ≥50% | At 12 months post-surgery | The rate of in-stent stenosis ≥50% |
Contacts
Primary ContactPengfei Yang, MD, PhD
Outcome results
None listed