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

Overview

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

• 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

Primary outcome measures

• Major recurrence, any stroke or death [Time frame: At 1 year post-surgery]

Secondary outcome measures (12)

• All-cause mortality [Time frame: At 12 months post-surgery]
• Any stroke [Time frame: At 12 months post-surgery]
• Major recurrence [Time frame: At 12 months post-surgery]
• Transient ischemic attack (TIA) [Time frame: At 12 months post-surgery]
• Procedure-related complications [Time frame: Periprocedural (30 days)]
• Ipsilateral stroke or neurologic death [Time frame: At 1 month and 12 months post-surgery]
• Severe disability [Time frame: At 1 month and 12 months post-surgery]
• Complete aneurysm occlusion [Time frame: at 12 months post-surgery]
• The rate of in-stent stenosis ≥50% [Time frame: At 12 months post-surgery]
• hemorrhagic stroke [Time frame: at 12 months post-surgery]
• Technical success rate [Time frame: 24 hours after endovascular treatment]
• Target parent artery retreatment rate [Time frame: At 12 months post-surgery]

Eligibility criteria

Inclusion criteria

• Age 18-75 years.
• Previously unruptured saccular cerebral aneurysm arising from intradural segments of the internal carotid artery and intracranial segments of the vertebral artery.
• Measuring ≤10mm in maximum diameter
• Subjects capable of understanding the study's purpose, willing to participate, and have signed an informed consent form.

Exclusion criteria

• Subjects with two or more multiple aneurysms requiring treatment within one year.
• Subjects with arteriovenous malformations or moyamoya disease.
• Subjects with ruptured, recurrent, or dissecting aneurysms.
• Subjects with symptomatic cerebral stenosis >70%;
• Subjects who have experienced a stroke (cerebral hemorrhage, cerebral infarction) within the past month.
• Clinical condition is extremely poor with a modified Rankin score of ≥3.
• Subjects planned for surgical/interventional procedures within three months.
• Subjects deemed inappropriate for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficult stent delivery, etc.).
• 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).
• Subjects unable to tolerate antiplatelet or anticoagulant therapy.
• Subjects who has had or are likely to have a severe reaction to contrast media.
• Subjects with a history of allergy to nickel-titanium, cobalt-chromium, or platinum-tungsten alloys.
• Subjects who have participated in other drug or medical device clinical trials and have not reached the primary endpoint time limit.
• Pregnant or breastfeeding women.
• Subjects with an expected lifespan of less than 12 months.
• Subjects deemed by the investigator to have poor compliance, unable to complete the study as required.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06600997 · PARAT-MT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗