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Recruiting NCT06446778

Pipeline Embolization for Intracranial Aneurysms

— Observational Efficacy, Self Hemodynamic Instability Stenosis Aneurysm, Intracranial

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pipeline embolization device with or without shield technique.
Who it may be relevant to
Registry conditions: Efficacy, Self, Hemodynamic Instability, Stenosis, Aneurysm, Intracranial. Basic parameters: 22 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Focus on Safety, Efficacy, and Haemodynamics

Overview

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.

Interventions

  • Device Pipeline embolization device with or without shield technique
    The patients undenwent Pipeline embolization device implantation with or without shield technique due to market availability, choice and preferences of the surgeon.

Primary outcome measures

  • The occlusion rate of the aneurysm [Time frame: 1 years]
Secondary outcome measures (2)
  • in-stent stenosis [Time frame: 1 years]
  • perioperative complications [Time frame: 1 months]

Eligibility criteria

Inclusion criteria

  • Aged 22 to 75 years old, male or non-pregnant female;
  • UIA was diagnosed by CTA, MRA, or DSA;
  • The size of aneurysms is between 3 to 25mm;
  • Understands the nature of the procedure and provision of written informed consent;
  • Indications for FD implantation with or without adjunctive coiling;
  • Is willing to return to the investigational site for follow-up according to our protocol.

Exclusion criteria

  • With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium;
  • Pregnancy or lactation;
  • Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);
  • Parent vessel with a diameter <2.0 mm or ≥5.0 mm.;
  • Unwilling to be followed up or likely to have poor treatment compliance;
  • Life expectancy less than 3 years;
  • Inability to receive anti-platelet or anticoagulant medication;
  • Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);
  • Enrollment in another trial or other situations that the researcher deems unsuitable for inclusion in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhujiang hospital — Guangzhou

Publications

  • Huang C, Zhu Y, Feng X, Tong X, Wen Z, Lin J, Huang M, Yuan H, Dai L, Chen W, Hu Y, Bi Y, Deng X, Xie Z, Shang G, Luo Y, Zhao Y, Peng C, Huang C, Su S, Zhang X, Li X, Guo Z, Liu A, Duan C. Stent match of pipeline embolization device: prediction of incomplete occlusion and in-stent stenosis by actual stent size after implantation. Neurosurg Rev. 2025 May 30;48(1):462. doi: 10.1007/s10143-025-03625- PMID 40442402
  • Huang J, Huang Y, Feng X, Huang C, Huang M, Wen Z, Xu A, Ge R, Yuan H, Shi H, Ma G, Li C, Lin J, Yi R, Hu Y, Jin Y, Liang S, Bi Y, Su S, Zhang X, Li X, Duan C. Predictive value of the systemic immune-inflammation index for periprocedural complications in flow diverter treatment for patients with intracranial aneurysms. Neurosurg Rev. 2024 Oct 22;47(1):809. doi: 10.1007/s10143-024-03053-0. PMID 39436476

Identifiers

NCT: NCT06446778 · LC2024ZD027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗