Pipeline Embolization for Intracranial Aneurysms

Zhujiang Hospital

Status: Enrolling

Conditions: Hemodynamic Instability; Aneurysm, Intracranial; Efficacy, Self; Stenosis

Treatments: Device: Pipeline embolization device with or without shield technique

Study type: Observational

Funder types: Other

Identifiers

NCT06446778

LC2024ZD027

Details and patient eligibility

About

This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization.

Full description

This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization. The primary outcomes were aneurysmal occlusion status, incidence of in-stent stenosis, and functional prognosis. The secondary outcomes were hemodynamic changes before and after stent implantation.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

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 design

1,000 participants in 2 patient groups

Saccular aneurysms

Description:

Patients with saccular aneurysms were enrolled.

Treatment:

Device: Pipeline embolization device with or without shield technique

Non-saccular aneurysms

Description:

Patients with non-saccular (i.e., fusiform, dissecting, blood blister-like) aneurysms were enrolled.

Treatment:

Device: Pipeline embolization device with or without shield technique