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

Naval Military Medical University

Status: Not yet enrolling

Conditions: Cerebral Aneurysm; Cerebral Aneurysm Unruptured

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06600997

PARAT-MT

Details and patient eligibility

About

A prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment.

Full 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.

Enrollment: 1,008 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,008 participants in 2 patient groups

Intervention group

Experimental group

Description:

Flow diversion for endovascular treatment of intracranial aneurysms

Treatment:

Device: Flow Diversion for Endovascular Treatment of Intracranial Aneurysms

Control group

Active Comparator group

Description:

Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms

Treatment:

Device: Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms