Pipeline Embolization for Intracranial Aneurysms

NCT06446778 | Recruiting DMC FDA Device

• 1 other identifier: LC2024ZD027
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Efficacy, Self; Hemodynamic Instability; Stenosis; Aneurysm, Intracranial

Keywords

intracranial aneurysms; flow-diverter device; Pipeline embolization device; in-stent stenosis

Outcome Measures

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).

  1 years

Secondary Outcomes (2)

• in-stent stenosis

  1 years

• perioperative complications

  1 months

Study Arms (2)

Saccular aneurysms

Patients with saccular aneurysms were enrolled.

Device: Pipeline embolization device with or without shield technique

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

Interventions

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.

Non-saccular aneurysms; Saccular aneurysms

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients underwent Pipeline implantation for intracranial aneurysms

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Zhujiang Hospital: lead
• 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

Study Sites (1)

Zhujiang hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (2)

• 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/s10143-025-03625-8.

  PMID: 40442402 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Constriction, Pathologic; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chuanzhi Duan, MD

  Zhujiang Hospital

  STUDY DIRECTOR

Central Study Contacts

Chuanzhi Duan, MD

CONTACT

020-62782757; doctor_duanzj@163.com

Xin Feng, MD

CONTACT

13681134001; 13681134001@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 6, 2024
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

CN (1)