Pipeline Embolization for Intracranial Aneurysms

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22-75
SponsorZhujiang Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.;

Trial population

Patients underwent Pipeline implantation for intracranial aneurysms

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Saccular aneurysms1 intervention
Group B: Non-saccular aneurysms1 intervention

Trial outcomes

Primary outcomes

1

The occlusion rate of the aneurysm

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).

Time frame
1 years

Secondary outcomes

1

in-stent stenosis

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 %)

Time frame
1 years
2

perioperative complications

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.

Time frame
1 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhujiang Hospital

Lead sponsor

Nanfang Hospital, Southern Medical University

Collaborator

Eighth Affiliated Hospital, Sun Yat-sen University

Collaborator

Zhongshan Hospital Of Traditional Chinese Medicine

Collaborator

First Affiliated Hospital of Jinan University

Collaborator

Beijing Tiantan Hospital

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

Affiliated Hospital of Southwest Medical University

Collaborator

Guangdong 999 Brain Hospital

Collaborator

Shantou Central Hospital

Collaborator

Guangdong Provincial People's Hospital

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator