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

N/AActive Not RecruitingNCT06715930

Beijing Tiantan Hospital1,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Intracranial Aneurysm

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged18 to 75 years; 2. IAs patients treated with PEDs; 3. patients whose parent artery did not have significant atherosclerotic stenosis; 4. patients who had at least one digital subtraction angiography (DSA) follow-up. Exclusion Criteria: 1. Patients missing critical clinical baseline; 2. patients with inadequate DSA image quality for reliable assessment; 3. patients with comorbid cerebrovascular conditions, including arteriovenous fistulas and arteriovenous malformations; 4. patients without any follow-up information.

Outcomes

Primary Outcomes

In-stent stenosis

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.

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

Secondary Outcomes

Complete occlusion at the last angiographic follow-up

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

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

Procedure-related complications

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.