Observing the effects of Pipeline embolization on 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Zhujiang hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Chuanzhi Duan, MD
• Email: doctor_duanzj@163.com
• Phone: 020-62782757

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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.