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

Capital Medical University

Status: Active, not recruiting

Conditions: Intracranial Aneurysm

Treatments: Procedure: Interventional treatment

Study type: Observational

Funder types: Other

Identifiers

NCT06715930

PED-ISS

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,500 participants in 2 patient groups

ISS group

Description:

Patients presenting with in-stent stenosis (ISS) at imaging follow-up. ISS 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 pipeline embolization device.

Treatment:

Procedure: Interventional treatment

Non-ISS group

Description:

Patients withou in-stent stenosis (ISS) at imaging follow-up. ISS 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 pipeline embolization device.

Treatment:

Procedure: Interventional treatment