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NCT Number: NCT06446778

Pipeline Embolization for Intracranial Aneurysms

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.

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Key information

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhujiang hospital

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Chuanzhi Duan

CONTACT

[email protected]

020-62782757

Xifeng Li, MD

SUB_INVESTIGATOR

Xin Feng, MD

SUB_INVESTIGATOR

Xin Zhang, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pipeline embolization device with or without shield technique

Device

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

Primary outcomes

  1. The occlusion rate of the aneurysm

    Time frame: 1 years

    The occlusion rate of the aneurysm at 6 months;O'Kelly Marotta classification: complete occlusion (D, entirely non-filling), near-complete occlusion (C, only entry remnant), and incomplete occlusion (A and B, subtotal and total filling).

Secondary outcomes

  1. in-stent stenosis

    Time frame: 1 years

    In-stent stenosis is defined as a growth process beyond the limits of stent mesh, which appears as a visible gap between the vessel lumen filled with contrast agent and stent struts.

    Stenosis ratio (SR) = [1-(actual diameter of the most stenotic segment with digital subtraction/actual diameter of stent measured on without digital subtraction)]*100%

    When there was no appreciable gap, cases were described as patency. Intimal hyperplasia was labeled when the SR was less than 25 %. ISS was defined as an SR of ≥ 25 %, and the stenosis grade was classified as mild (25 % to 49 %), severe (50 % to 99 %), or lumen occlusion (SR = 100 %)

  2. perioperative complications

    Time frame: 1 months

    perioperative complications;such as arterial perforation, iatrogenic arterial dissection, embolization in previously uninvolved vascular territory, arterial access site hematoma, and retroperitoneal hematoma. Arterial perforation will be defined at angiography by the operator and associated with subarachnoid hemorrhage. Iatrogenic arterial dissection will be defined at angiography by the operator. Arterial access site hematoma will be assessed as a complication of arterial access puncture and defined by clinical examination and anatomic imaging. Retroperitoneal hematoma will be assessed as a complication of groin puncture and defined by imaging (ultrasound or CT or MR angiography). The definition of embolization in previously uninvolved vascular territory is noted after recanalization of the primary occlusion site, any vessel occlusions distal from the primary occlusion site are considered emboli due to periprocedural thrombus fragmentation.

Study contacts

Contact information is provided by the study sponsor or research team.

Chuanzhi Duan, MD

CONTACT

[email protected]

020-62782757

Xin Feng, MD

CONTACT

[email protected]

13681134001

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Collaborators

  • Affiliated Hospital of Southwest Medical University
  • Beijing Tiantan Hospital
  • Eighth Affiliated Hospital, Sun Yat-sen University
  • First Affiliated Hospital of Chongqing Medical University
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Jinan University
  • Guangdong 999 Brain Hospital
  • Guangdong Provincial People's Hospital
  • Nanfang Hospital, Southern Medical University
  • Shantou Central Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Zhongshan Hospital Of Traditional Chinese Medicine

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2030
First posted
Jun 6, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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