Stent match of pipeline embolization device: prediction of incomplete occlusion and in-stent stenosis by actual stent size after implantation.
Chi Huang, Yajun Zhu, Xin Feng...
https://pubmed.ncbi.nlm.nih.gov/40442402Actively Recruiting
Age: 22Years - 75Years
All Genders
ID06446778
Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Study on Safety, Efficacy, and Haemodynamics
Led by Zhujiang Hospital · Updated on 2024-11-18
1000
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhujiang Hospital
Lead Sponsor
N
Nanfang Hospital, Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting clinical, laboratory, and imaging data from adults aged 22 to 75 years with intracranial aneurysms who undergo Pipeline embolization device implantation. This observational study aims to observe the safety, effectiveness, and blood flow changes after treatment with the Pipeline embolization device, focusing on both saccular and non-saccular aneurysms. The study is sponsored by Zhujiang Hospital and seeks to advance understanding of this treatment's impact over time. Participants receive the Pipeline embolization device implantation with or without the shield technique based on availability and surgeon preference. The study includes patients with aneurysms sized between 3 to 25 mm, with follow-up scheduled to monitor outcomes. Two main groups include those with saccular aneurysms and those with non-saccular aneurysms such as fusiform or dissecting types. During the study, researchers will assess aneurysm occlusion rates at one year, incidence of in-stent stenosis, and perioperative complications within one month. Participants will be monitored through clinical evaluations, imaging scans, and laboratory tests to evaluate the treatment's effect on blood flow and vessel condition. Follow-up visits are required to ensure adherence and assess functional prognosis, with ongoing observation until the study's completion in 2030.
CONDITIONS
Brief Title
Pipeline Embolization for Intracranial Aneurysms
Who Can Participate
Age: 22Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 22 to 75 years old, male or non-pregnant female
- Diagnosed with unruptured intracranial aneurysm by CTA, MRA, or DSA
- Aneurysm size between 3 to 25 millimeters
- Understands the procedure and provides written informed consent
- Indicated for flow diverter implantation with or without adjunctive coiling
- Willing to return for follow-up visits according to the study protocol
You will not qualify if you...
- Contraindications to flow-diversion treatment or allergy to cobalt-chromium alloy or contrast medium
- Pregnant or lactating females
- Presence of other vascular lesions such as coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, or Moyamoya disease
- Parent vessel diameter less than 2.0 mm or greater than or equal to 5.0 mm
- Unwillingness or inability to comply with follow-up
- Life expectancy less than 3 years
- Unable to receive anti-platelet or anticoagulant medication
- Severe neurological deficits preventing independent living (modified Rankin score 4 or higher)
- Participation in another trial or other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - 1 day
Participants undergo implantation of the Pipeline embolization device with or without shield technique as part of their treatment for intracranial aneurysms.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - 1 year
Participants are monitored for safety, efficacy, and hemodynamic changes following the device implantation.
Follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Zhujiang hospital
Guangzhou, Guangdong, China
Actively Recruiting
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Research Team
C
Chuanzhi Duan, MD
X
Xin Feng, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Predictive value of the systemic immune-inflammation index for periprocedural complications in flow diverter treatment for patients with intracranial aneurysms.
Jiwan Huang, Yaxian Huang, Xin Feng...
https://pubmed.ncbi.nlm.nih.gov/39436476