Pipeline Embolization for Intracranial Aneurysms

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

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.

Study Overview

• Status: Recruiting
• Conditions: Efficacy, Self; Stenosis; Hemodynamic Instability; Aneurysm, Intracranial
• Intervention / Treatment: Device: Pipeline embolization device with or without shield technique

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Chuanzhi Duan, MD; Phone Number: 020-62782757; Email: doctor_duanzj@163.com
• Study Contact Backup: Name: Xin Feng, MD; Phone Number: 13681134001; Email: 13681134001@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Zhujiang Hospital
      • Principal Investigator: Xin Zhang, MD
      • Contact: Chuanzhi Duan; Phone Number: 020-62782757; Email: doctor_duanzj@163.com
      • Sub-Investigator: Xin Feng, MD
      • Sub-Investigator: Xifeng Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients underwent Pipeline implantation for intracranial aneurysms

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Saccular aneurysms; Patients with saccular aneurysms were enrolled.	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.
Non-saccular aneurysms; Patients with non-saccular (i.e., fusiform, dissecting, blood blister-like) aneurysms were enrolled.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 %)	1 years
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.	1 months

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Beijing Tiantan Hospital; The First Affiliated Hospital of Zhengzhou University; Guangdong Provincial People's Hospital; First Affiliated Hospital of Jinan University; Shantou Central Hospital; First Affiliated Hospital of Chongqing Medical University; First Affiliated Hospital of Harbin Medical University; Guangdong 999 Brain Hospital; Affiliated Hospital of Southwest Medical University; Eighth Affiliated Hospital, Sun Yat-sen University; Zhongshan Hospital Of Traditional Chinese Medicine; Nanfang Hospital, Southern Medical University
• Investigators: Study Director: Chuanzhi Duan, MD, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: intracranial aneurysms; in-stent stenosis; Pipeline embolization device; flow-diverter device
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: LC2024ZD027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes