Cerebral Aneurysm UnrupturedNCT06600997
Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers: a Multicenter Randomized Trial(PARAT-MT)
A study testing Flow Diversion for Endovascular Treatment of Intracranial Aneurysms and Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms in people with Cerebral Aneurysm Unruptured and Cerebral Aneurysm, run by Changhai Hospital.
Trial summary
A prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Aneurysm Unruptured, Cerebral Aneurysm
- What is being tested?
- Flow Diversion for Endovascular Treatment of Intracranial Aneurysms and Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 30 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A prospective, multicenter, randomized controlled clinical trial with open-label treatment and blinded endpoint assessment.
Read the 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
- All-cause mortality at 12 months post-surgery.
- Any stroke at 12 months post-surgery.
- Major recurrence rate at 12 months post-surgery.
- Transient ischemic attack (TIA) occurrence rate at 12 months post-surgery.
- Periprocedural (30-day) procedure-related complications rate.
- Ipsilateral stroke or neurologic death at 1 month and 12 months post-surgery
- Severe disability rate at 1 month and 12 months post-surgery (mRS > 2).
- Complete aneurysm occlusion rate at 12 months post-surgery (Raymond I).
- The rate of in-stent stenosis ≥50% at 12 months post-surgery.
- Incidence of hemorrhagic stroke at 12 months post-surgery.
- Technical success rate.
- Target parent artery retreatment rate at 12 months post-surgery.
- Target aneurysm retreatment rate at 12 months post-surgery.
- Surgical operation time.
- Radiation dose.
- Conditions
- Cerebral Aneurysm Unruptured, Cerebral Aneurysm
- Being tested
- 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
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow Diversion for Endovascular Treatment of Intracranial AneurysmsDevice
Flow Diversion for Endovascular Treatment of Intracranial Aneurysms
Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysmsDevice
Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Flow diversion for endovascular treatment of intracranial aneurysms Receives: Device: Flow Diversion for Endovascular Treatment of Intracranial Aneurysms |
| Control group | Active comparator | Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms Receives: Device: Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major recurrence, any stroke or death
A composite endpoint of major recurrence, any stroke or death
Measured: At 1 year post-surgery
Secondary outcomes (15)
All-cause mortality
All-cause mortality
Measured: At 12 months post-surgery
Any stroke
Any stroke
Measured: At 12 months post-surgery
Major recurrence
Major recurrence
Measured: At 12 months post-surgery
Transient ischemic attack (TIA)
Transient ischemic attack (TIA)
Measured: At 12 months post-surgery
Procedure-related complications
Procedure-related complications
Measured: Periprocedural (30 days)
Ipsilateral stroke or neurologic death
Ipsilateral stroke or neurologic death
Measured: At 1 month and 12 months post-surgery
Severe disability
Severe disability (mRS > 2)
Measured: At 1 month and 12 months post-surgery
Complete aneurysm occlusion
Complete aneurysm occlusion (Raymond I)
Measured: at 12 months post-surgery
The rate of in-stent stenosis ≥50%
The rate of in-stent stenosis ≥50%
Measured: At 12 months post-surgery
hemorrhagic stroke
Incidence of hemorrhagic stroke
Measured: at 12 months post-surgery
Technical success rate
Technical success rate
Measured: 24 hours after endovascular treatment
Target parent artery retreatment rate
Target parent artery retreatment rate
Measured: At 12 months post-surgery
Target aneurysm retreatment rate
Target aneurysm retreatment rate
Measured: At 12 months post-surgery
Surgical operation time
Surgical operation time
Measured: during surgery
Radiation dose
Radiation dose
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jan 2025 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Aneurysm UnrupturedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,008 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, MD, PhD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600997
- Sponsor's protocol ID
- PARAT-MT
- Status last verified
- Dec 2024
- First submitted
- 14 Sep 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers: a Multicenter Randomized Trial(PARAT-MT)
- ClinicalTrials.gov ID
- NCT06600997
- Acronym / sponsor ID
- PARAT-MT
- Conditions
- Cerebral Aneurysm Unruptured, Cerebral Aneurysm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,008 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2031 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- All-cause mortality at 12 months post-surgery.
- Any stroke at 12 months post-surgery.
- Major recurrence rate at 12 months post-surgery.
- Transient ischemic attack (TIA) occurrence rate at 12 months post-surgery.
- Periprocedural (30-day) procedure-related complications rate.
- Ipsilateral stroke or neurologic death at 1 month and 12 months post-surgery
- Severe disability rate at 1 month and 12 months post-surgery (mRS > 2).
- Complete aneurysm occlusion rate at 12 months post-surgery (Raymond I).
- The rate of in-stent stenosis ≥50% at 12 months post-surgery.
- Incidence of hemorrhagic stroke at 12 months post-surgery.
- Technical success rate.
- Target parent artery retreatment rate at 12 months post-surgery.
- Target aneurysm retreatment rate at 12 months post-surgery.
- Surgical operation time.
- Radiation dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Flow Diversion for Endovascular Treatment of Intracranial AneurysmsFlow diversion for endovascular treatment of intracranial aneurysms |
| Control group | Active comparator | Device: Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysmsConventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow Diversion for Endovascular Treatment of Intracranial AneurysmsFlow Diversion for Endovascular Treatment of Intracranial Aneurysms | Device | Intervention group |
| Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysmsConventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms | Device | Control group |
Primary outcome
Major recurrence, any stroke or death
Time frame: At 1 year post-surgery
A composite endpoint of major recurrence, any stroke or death
15 secondary outcomes
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
Target aneurysm retreatment rate
Time frame: At 12 months post-surgery
Surgical operation time
Time frame: during surgery
Radiation dose
Time frame: during surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Yes. Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianmin Liu, MD, PhD principal investigator
Changhai Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Flow Diversion for Endovascular Treatment of Intracranial Aneurysms and Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms in people with Cerebral Aneurysm Unruptured and Cerebral Aneurysm, run by Changhai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengfei Yang, MD, PhD (86-21-31161784, 15921196312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major recurrence, any stroke or death (time frame: At 1 year post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.