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

Not Applicable

Not yet recruiting

• Conditions: Cerebral Aneurysm Unruptured; Cerebral Aneurysm
• Interventions: Device: 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

• Registration Number: NCT06600997
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study First Submitted: 2024-09-14
• Study First Submitted QC: 2024-09-14
• Study First Posted: 2024-09-19
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-01
• Last Update Posted: 2025-01-03
• Study Start: 2025-01-15
• Primary Completion: 2027-10-30
• Study Completion: 2031-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1008

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Flow Diversion for Endovascular Treatment of Intracranial Aneurysms	Flow diversion for endovascular treatment of intracranial aneurysms
Control group	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

Primary Outcome Measures

Name	Time	Method
Major recurrence, any stroke or death	At 1 year post-surgery	A composite endpoint of major recurrence, any stroke or death

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	At 12 months post-surgery	All-cause mortality
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)
The rate of in-stent stenosis ≥50%	At 12 months post-surgery	The rate of in-stent stenosis ≥50%
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