Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy

NCT06456697 | Recruiting

• 1 other identifier: KS2023004
• Study Type: observational
• Target: 482
• Locations: 1 country
• Sites: 1

Brief Summary

Since its launch in China in 2014, Pipeline Embolization Device (PED) has been widely used in the treatment of intracranial aneurysms. It is necessary to collect data on the long-term safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms, analyze its long-term effectiveness, and provide guidance for clinical practice.

Conditions

Treatment

Keywords

intracranial aneurysm; Pipeline

Outcome Measures

Primary Outcomes (3)

• Rate of complete aneurysm occlusion in 5 years

  The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond-Roy occlusion classification Scale at the 5 year follow-up angiographic assessments will be evaluated.

  assessed at 5 years (plus or minus 6 months)after procedure

• Rate of parent artery stenosis in 5 years

  Severe stenosis is defined as stenosis greater than 50%.

  assessed at 5 years (plus or minus 6 months)after procedure

• Patient prognosis in 5 years

  Assessing patient prognosis using Modified Rankin Scale (mRS) scores. mRS is scored on a scale of 0 to 6, with a higher score indicating a more severe condition.

  assessed at 5 years (plus or minus 6 months)after procedure

Secondary Outcomes (3)

• Device-related neurologic adverse event in 5 years

  assessed at 5 years (plus or minus 6 months)after procedure

• Occurrence of major stroke or neurovascular death in 5 years

  assessed at 5 years (plus or minus 6 months)after procedure

• Brain Vascular Accident Leading to Death in 5 years

  assessed at 5 years (plus or minus 6 months)after procedure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study was conducted in 10 centers in the country. According to previous literature, the reported occlusion rate ranges from 81.4% to 95.2% \[8-12\], and the occlusion rate increases with longer follow-up time. In this study, the occlusion rate was calculated at 90%, with a permissible error control of 3%. With α=0.05, the sample size was calculated to be 385. Anticipating a dropout rate of 20%, the sample size needed is 482 cases.

You may qualify if:

• The patient was diagnosed with intracranial aneurysms using digital subtraction angiography (DSA).
• The pipeline was successfully placed to treat intracranial aneurysms.

You may not qualify if:

• Patients had undergone surgery or interventional treatment before enrollment.
• During treatment, other types of stents are used in combination.
• Unable to complete the follow-up.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Henan Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Beijing Tiantan Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• peng zhang, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

peng zhang, MD

CONTACT

010-83198899; zhangpengwr@126.com

Yongjie Ma, MD

CONTACT

010-83198899; mayongjiedoctor@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 13, 2024
• Study Start: December 30, 2021
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-05

Locations

CN (1)