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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06474884

Enrollment

165

Registered

2024-06-26

Start date

2024-01-01

Completion date

2025-12-30

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment

Keywords

intracranial aneurysm

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.).

Countries

China

Outcome results