Observing the effects of Pipeline embolization on intracranial aneurysms
Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Focus on Safety, Efficacy, and Haemodynamics
This study looks at how well the Pipeline device works and its safety for people with brain aneurysms who have had it implanted.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06446778 on ClinicalTrials.gov |
What this trial studies
This observational study collects clinical, laboratory, and imaging data from patients with intracranial aneurysms who have undergone Pipeline implantation. The aim is to evaluate the safety and efficacy of the Pipeline embolization device, focusing on aneurysmal occlusion status, incidence of in-stent stenosis, and functional prognosis. Additionally, the study assesses hemodynamic changes before and after the stent implantation. The data gathered will help in understanding the outcomes associated with this treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 22 to 75 with diagnosed unruptured intracranial aneurysms suitable for Pipeline embolization.
Not a fit: Patients with contraindications to flow-diversion treatment, other significant vascular lesions, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with intracranial aneurysms, potentially leading to better outcomes and reduced complications.
How similar studies have performed: Other studies using flow-diverter devices for treating intracranial aneurysms have shown promising results, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Aged 22 to 75 years old, male or non-pregnant female; 2. UIA was diagnosed by CTA, MRA, or DSA; 3. The size of aneurysms is between 3 to 25mm; 4. Understands the nature of the procedure and provision of written informed consent; 5. Indications for FD implantation with or without adjunctive coiling; 6. Is willing to return to the investigational site for follow-up according to our protocol. Exclusion criteria: 1. With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium; 2. Pregnancy or lactation; 3. Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.); 4. Parent vessel with a diameter \<2.0 mm or ≥5.0 mm.; 5. Unwilling to be followed up or likely to have poor treatment compliance; 6. Life expectancy less than 3 years; 7. Inability to receive anti-platelet or anticoagulant medication; 8. Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4); 9. Enrollment in another trial or other situations that the researcher deems unsuitable for inclusion in the study.
Where this trial is running
Guangzhou, Guangdong
- Zhujiang hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Chuanzhi Duan, MD
- Email: doctor_duanzj@163.com
- Phone: 020-62782757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.