Clinical trial NCT06600997: Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers: a Multicenter Randomized Trial(PARAT-MT)
Official title: Parent Artery Reconstruction for Small Unruptured Cerebral Aneurusms Using Flow DiverTers: a Multicenter Randomized Trial(PARAT-MT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Aneurysm Unruptured
Cerebral Aneurysm
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1008
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major recurrence, any stroke or death
timeFrame: At 1 year post-surgery
Secondary outcomes:
measure: All-cause mortality
timeFrame: At 12 months post-surgery
measure: Any stroke
timeFrame: At 12 months post-surgery
measure: Major recurrence
timeFrame: At 12 months post-surgery
measure: Transient ischemic attack (TIA)
timeFrame: At 12 months post-surgery
measure: Procedure-related complications
timeFrame: Periprocedural (30 days)
measure: Ipsilateral stroke or neurologic death
timeFrame: At 1 month and 12 months post-surgery
measure: Severe disability
timeFrame: At 1 month and 12 months post-surgery
measure: Complete aneurysm occlusion
timeFrame: at 12 months post-surgery
measure: The rate of in-stent stenosis ≥50%
timeFrame: At 12 months post-surgery
measure: hemorrhagic stroke
timeFrame: at 12 months post-surgery
measure: Technical success rate
timeFrame: 24 hours after endovascular treatment
measure: Target parent artery retreatment rate
timeFrame: At 12 months post-surgery
measure: Target aneurysm retreatment rate
timeFrame: At 12 months post-surgery
measure: Surgical operation time
timeFrame: during surgery
measure: Radiation dose
timeFrame: during surgery
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: