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Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients with Intracranial Aneurysm

NCT06715930 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2024-12-04

No results posted yet for this study

Summary

Intracranial aneurysms (IAs) are the primary cause of non-traumatic subarachnoid hemorrhage with high morbidity and mortality. Flow diverters, such as pipeline embolization devices (PEDs), are among the most effective methods for treating IAs in recent years due to the maturity of interventional devices and minimally invasive techniques. Unlike conventional stents, PEDs modify the hemodynamics within the parent artery and aneurysm sac, allowing blood flow from the aneurysm sac, thus facilitating endothelialization of the aneurysm neck. As a result, aneurysms are completely removed from circulation with time. However, about 5.1%-38.5% of IA patients develop in-stent stenosis (ISS) even after successful PED implantation. ISS increases the risk of retreatment and ischemic complications, thereby affecting the long-term prognosis of IA patients. Therefore, preoperative determination of the patient's suitability for PED implantation can enhance patient-centered decision-making and improve the long-term prognosis of IA patients.

Although previous studies have evaluated the correlation between certain individual variables and ISS, there are few comprehensive models predicting ISS after PED treatment. Nomograms have been widely used for prediction of tumor survival and cardiovascular events. Nomograms incorporate multiple risk factors for predicting the patient's potential prognosis based on their individual risks. This study aimed to identify the predictors for ISS after PED treatment and to create and verify a nomogram for assessing individual risk.

Conditions

  • Intracranial Aneurysm

Interventions

PROCEDURE

Interventional treatment

The procedure was performed via the traditional transfemoral arterial approach, under general anesthesia and complete heparin anticoagulation. PEDs were introduced using Marksman or Phenom-27 microcatheters (Medtronic, Irvine, USA), while coils were introduced via Echelon-10 microcatheters (Medtronic, Dublin, Ireland). An appropriate working projection was used to generate three-dimensional rotational angiography. Un-subtracted images were used to verify whether PED was completely deployed and attached to the parent artery. Wall apposition was enhanced using balloon angioplasty if post-deployment imaging indicated inadequate apposition. Overlapping devices were used when a single PED was not enough to cover the aneurysm neck and reconstruct blood flow. Neurointerventionalists with more than 15 years of experience conducted all endovascular procedures. The same dual-antiplatelet therapy was used for 6 months post-procedure, followed by aspirin monotherapy for a minimum of 12 months.

Sponsors & Collaborators

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Peking University International Hospital

    collaborator OTHER

  • Beijing Tiantan Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2023-10-01
Completion
2025-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715930 on ClinicalTrials.gov