Clinical trial NCT06446778: Pipeline Embolization for Intracranial Aneurysms
Official title: Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Focus on Safety, Efficacy, and Haemodynamics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Efficacy, Self
Hemodynamic Instability
Stenosis
Aneurysm, Intracranial
Keywords: intracranial aneurysms
flow-diverter device
Pipeline embolization device
in-stent stenosis
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Eighth Affiliated Hospital, Sun Yat-sen University
name: Zhongshan Hospital Of Traditional Chinese Medicine
name: First Affiliated Hospital of Jinan University
name: Beijing Tiantan Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: Affiliated Hospital of Southwest Medical University
name: Guangdong 999 Brain Hospital
name: Shantou Central Hospital
name: Guangdong Provincial People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: First Affiliated Hospital of Harbin Medical University
First posted: 2024-06-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent Pipeline implantation for intracranial aneurysms

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: The occlusion rate of the aneurysm
timeFrame: 1 years
Secondary outcomes:
measure: in-stent stenosis
timeFrame: 1 years
measure: perioperative complications
timeFrame: 1 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang hospital
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Chuanzhi Duan, MD
role: STUDY_DIRECTOR
References: