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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Aneurysm; Cerebral Aneurysm Unruptured
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 1008
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pengfei Yang, MD, PhD; Phone Number: 86-21-31161784; Email: 15921196312@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Flow diversion for endovascular treatment of intracranial aneurysms	Device: Flow Diversion for Endovascular Treatment of Intracranial Aneurysms; Flow Diversion for Endovascular Treatment of Intracranial Aneurysms
Active Comparator: Control group; 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; Conventional endovascular therapy (stent-assisted coiling, balloon-assisted coiling, or coiling) for endovascular treatment of intracranial aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major recurrence, any stroke or death	A composite endpoint of major recurrence, any stroke or death	At 1 year post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	At 12 months post-surgery
Any stroke	Any stroke	At 12 months post-surgery
Major recurrence	Major recurrence	At 12 months post-surgery
Transient ischemic attack (TIA)	Transient ischemic attack (TIA)	At 12 months post-surgery
Procedure-related complications	Procedure-related complications	Periprocedural (30 days)
Ipsilateral stroke or neurologic death	Ipsilateral stroke or neurologic death	At 1 month and 12 months post-surgery
Severe disability	Severe disability (mRS > 2)	At 1 month and 12 months post-surgery
Complete aneurysm occlusion	Complete aneurysm occlusion (Raymond I)	at 12 months post-surgery
The rate of in-stent stenosis ≥50%	The rate of in-stent stenosis ≥50%	At 12 months post-surgery
Technical success rate	Technical success rate	24 hours after endovascular treatment
Target parent artery retreatment rate	Target parent artery retreatment rate	At 12 months post-surgery
Target aneurysm retreatment rate	Target aneurysm retreatment rate	At 12 months post-surgery
hemorrhagic stroke	Incidence of hemorrhagic stroke	at 12 months post-surgery
Surgical operation time	Surgical operation time	during surgery
Radiation dose	Radiation dose	during surgery

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Jianmin Liu, MD, PhD, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2031

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: September 14, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 1, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: PARAT-MT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• IPD Sharing Access Criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered.; The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials.; Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research.; Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection.; The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No