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NCT Number: NCT06715930

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged18 to 75 years;
  • IAs patients treated with PEDs;
  • patients whose parent artery did not have significant atherosclerotic stenosis;
  • patients who had at least one digital subtraction angiography (DSA) follow-up.

Exclusion criteria

  • Patients missing critical clinical baseline;
  • patients with inadequate DSA image quality for reliable assessment;
  • patients with comorbid cerebrovascular conditions, including arteriovenous fistulas and arteriovenous malformations;
  • patients without any follow-up information.

Treatment and study plan

Interventional treatment

Procedure

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.

Primary outcomes

  1. In-stent stenosis

    Time frame: 6 months, 1 year, and 3 years after treatment.

    In-stent stenosis was defined as a growth process exceeding the limits of metal mesh, as evidenced by a visible gap between the contrast-filled vascular lumen and the internal contours of the PED.

Secondary outcomes

  1. Complete occlusion at the last angiographic follow-up

    Time frame: 6 months, 1 year, and 3 years after treatment

    At follow-up, the patient's aneurysm was completely occluded, with an OKM score of grade D.

    O'Kelly-Marotta grading scale was used to assess aneurysm occlusion status following PED treatment. Grade D indicated complete occlusion, while grades A, B, and C represented incomplete occlusion

  2. Procedure-related complications

    Time frame: 6 months, 1 year, and 3 years after treatment

    Procedure-related complications were divided into hemorrhagic, ischemic, and compression symptoms. Hemorrhagic complications were defined as subarachnoid hemorrhage or distal intraparenchymal hemorrhage after PED implantation. Ischemic complications included in-stent thrombosis, transient ischemic attack, or cerebral infarction associated with the treated vascular area. Compression symptoms included neurological symptoms or brain stem symptoms associated with aneurysm compression.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Peking University International Hospital

Registry information

Official study title

Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients With Intracranial Aneurysm: a Multicenter, Retrospective Model Development and Validation Study

Acronym: PED-ISS

Important dates

Study start
2016
Primary completion
2023
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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