Surface-modified Flow Diverters for Unruptured Intracranial Aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter randomized controlled trial comparing the PED Shield and the Lattice Flow Diverter in adults with unruptured intracranial aneurysms treated endovascularly. Participants are assigned to receive one of the two devices, with outcomes focused on ischemic events and clinical status after treatment. Eligible patients must have a suitable target aneurysm, be 18–75 years old, and provide informed consent. The trial aims to provide prospective, head-to-head data on device performance to reduce procedure-related ischemia. Lead sites include Henan Provincial People's Hospital and collaborating centers in Henan, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients were diagnosed with unruptured intracranial aneurysms, and the lesions were evaluated to be suitable for endovascular treatment with flow diverter devices (PED Shield/Lattice).
2. During the study period, only one target aneurysm per patient was treated, with the exception of segmental lesions, in which multiple aneurysms located within the same arterial segment were treated with a single or overlapping study devices.
3. The target aneurysm was treated solely with flow diverter (FD) implantation in the current study.
4. The age of enrolled patients ranged from 18 to 75 years old.
5. Patients were capable of understanding the study-related informed consent information and provided written informed consent for the use of their clinical data for research purposes.

Exclusion Criteria:

1. Patients with a prior history of endovascular treatment for the target aneurysm.
2. Patients in the acute stage of cerebrovascular diseases (acute cerebral infarction or intracerebral hemorrhage with an onset time of ≤ 2 weeks).
3. Patients complicated with other cerebrovascular disorders, including moyamoya disease, cerebrovascular malformations, and arteriovenous fistula.
4. Patients with atherosclerotic changes in the parent artery of the target aneurysm that necessitated additional intraoperative endovascular interventions (e.g., balloon angioplasty or conventional stent implantation).
5. Patients with a preoperative modified Rankin Scale (mRS) score greater than 2.
6. Patients with any absolute contraindications to device treatment as specified in the Instructions for Use (IFU).
7. Patients enrolled in other clinical trials that may interfere with the primary or secondary endpoints of the present study.
8. Patients with comorbidities that may interfere with neurological function evaluation, affect survival status, or impair the ability to complete follow-up visits.
9. Pregnant or lactating female patients.

Where it's running

• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Li Li, MD
• Email: lli120253@163.com
• Phone: +8615038063905

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.