The Safety and Efficacy of Single Antiplatelet Therapy After Pipeline Flex with Shield for Intracranial Aneurysms

Capital Medical University

Status: Enrolling

Conditions: Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT06474884

zp930826

Details and patient eligibility

About

The objective of this study was to evaluate the safety and efficacy of single antiplatelet therapy after Pipeline flex with Shield stent implantation for intracranial aneurysms.

Full description

Title：A single-center, prospective, cohort study of the safety and efficacy of Single Antiplatelet therapy after Pipeline flex with Shield stent implantation for intracranial aneurysms.

Purpose：To assess the safety and efficacy of single antiplatelet therapy after Pipeline flex with Shield stent implantation for intracranial aneurysms.

Follow up:The follow-up period was 6 months.

Enrollment: 165 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with unruptured intracranial aneurysms who received the intracranial Pipeline Flex with Shield stent.
2. Vascular conditions:

1. There was no obvious calcification and stenosis of the parent artery. 2) The curvature of the bearing artery is minimal. 3) The parent artery diameter ≥2.5mm

3.According to the committee's assessment, only one Pipeline flex with shield is needed for aneurysm treatment.

4.Before the stent implantation procedure, standard dual antiplatelet therapy should be administered for at least 3 days.

5.Patients with an Modified Rankin Scale(mRS) score of less than 2 on the day of registration.

6.The operation was successful, and immediate postoperative angiography indicated good wall apposition.

Exclusion criteria

1. Patients with recurrent aneurysms after interventional treatment or surgical clipping.
2. The patient after stent placement surgery.
3. Aneurysms can have irregular shapes, such as fusiform, blister-type, or dissecting aneurysms.
4. The patient had no history of stroke or aneurysm rupture in the last 3 months.
5. Abnormal platelet function, or platelet count < 100,000 cells/mm³.
6. Known history of allergy to clopidogrel or heparin.