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

Xuanwu Hospital, Beijing165 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

165

Conditions

Treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

Rate of complete aneurysm occlusion in 6 months

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.

Time frame: assessed at 6 months after procedure

Hemorrhagic, ischemic events, or neurological deficits occurring within 6 months postoperatively.

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.).

Time frame: assessed at 6 months after procedure

Data from ClinicalTrials.gov

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