Pipeline Embolization for Intracranial Aneurysms

Launched by ZHUJIANG HOSPITAL · Jun 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special device called a Pipeline to treat intracranial aneurysms, which are weak spots in the blood vessels of the brain that can be dangerous. The main goals of the study are to see how safe the Pipeline is, how well it works to treat these aneurysms, and how it affects blood flow in the brain after the procedure. Researchers are currently looking for participants who are between 22 and 75 years old, who have a specific type of aneurysm that is between 3 to 25 millimeters in size, and who understand the procedure well enough to give their consent to join.

If you or a loved one decide to participate, you'll undergo the Pipeline implantation and will need to return for follow-up visits as part of the study. It's important to note that certain individuals won't be eligible to join, including those who are pregnant, have certain other medical conditions, or cannot take certain medications. This study aims to contribute valuable information about treating brain aneurysms, so if you meet the criteria and are interested, it could be a chance to help advance medical knowledge in this area.

Gender

ALL

Eligibility 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.

Trial Officials