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

NCT06600997 | Not Yet Recruiting DMC

• 1 other identifier: PARAT-MT
• Study Type: interventional
• Target: 1,008
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Cerebral Aneurysm Unruptured; Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

• Major recurrence, any stroke or death

  A composite endpoint of major recurrence, any stroke or death

  At 1 year post-surgery

Secondary Outcomes (15)

• All-cause mortality

  At 12 months post-surgery

• Any stroke

  At 12 months post-surgery

• Major recurrence

  At 12 months post-surgery

• Transient ischemic attack (TIA)

  At 12 months post-surgery

• Procedure-related complications

  Periprocedural (30 days)

Study Arms (2)

Intervention group

EXPERIMENTAL

Flow diversion for endovascular treatment of intracranial aneurysms

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

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

Interventions

Flow Diversion for Endovascular Treatment of Intracranial Aneurysms DEVICE

Flow Diversion for Endovascular Treatment of Intracranial Aneurysms

Intervention 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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin Liu, MD, PhD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pengfei Yang, MD, PhD

CONTACT

86-21-31161784; 15921196312@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 19, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2031
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data sharing will be available from 12 months after the publication of the main results.
• Access Criteria: 1. 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. 2. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. 3. 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. 4. 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. 5. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.