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

Recruiting

• Conditions: Treatment

• Registration Number: NCT06474884
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Study First Posted: 2024-06-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Primary Completion: 2024-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemorrhagic, ischemic events, or neurological deficits occurring within 6 months postoperatively.	assessed at 6 months after procedure	Ischemic events include intraoperative and postoperative ischemic stroke, transient ischemic attack, stent thrombosis, emergency revascularization, and cerebrovascular death.; Hemorrhagic events include: symptomatic or asymptomatic intracranial hemorrhagic events (subarachnoid hemorrhage and intracerebral hemorrhage) within 6 months after surgery; or non-intracranial hemorrhagic events (such as skin petechiae, epistaxis, gingival bleeding, gastrointestinal bleeding, genitourinary bleeding, etc.).
Rate of complete aneurysm occlusion in 6 months	assessed at 6 months after procedure	The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond-Roy occlusion classification Scale at the 6 months follow-up angiographic assessments will be evaluated.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China