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

ConditionsCerebral Aneurysm UnrupturedCerebral Aneurysm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChanghai Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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%;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Flow Diversion for Endovascular Treatment of Intracranial Aneurysms

    Device

    Flow Diversion for Endovascular Treatment of Intracranial Aneurysms

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

    Device

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

Treatment groups

1,008 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Major recurrence, any stroke or death

A composite endpoint of major recurrence, any stroke or death

Time frame
At 1 year post-surgery

Secondary outcomes

1

All-cause mortality

All-cause mortality

Time frame
At 12 months post-surgery
2

Any stroke

Any stroke

Time frame
At 12 months post-surgery
3

Major recurrence

Major recurrence

Time frame
At 12 months post-surgery
4

Transient ischemic attack (TIA)

Transient ischemic attack (TIA)

Time frame
At 12 months post-surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changhai Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: