The Safety and Efficacy of Single Antiplatelet Therapy After Pipeline Flex with Shield for Intracranial Aneurysms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Treatment. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
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.
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.
Primary outcome measures
- Rate of complete aneurysm occlusion in 6 months [Time frame: assessed at 6 months after procedure]
- Hemorrhagic, ischemic events, or neurological deficits occurring within 6 months postoperatively. [Time frame: assessed at 6 months after procedure]
Eligibility criteria
Inclusion criteria
- Patients with unruptured intracranial aneurysms who received the intracranial Pipeline Flex with Shield stent.
- 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
- Patients with recurrent aneurysms after interventional treatment or surgical clipping.
- The patient after stent placement surgery.
- Aneurysms can have irregular shapes, such as fusiform, blister-type, or dissecting aneurysms.
- The patient had no history of stroke or aneurysm rupture in the last 3 months.
- Abnormal platelet function, or platelet count < 100,000 cells/mm³.
- Known history of allergy to clopidogrel or heparin.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xuanwu Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06474884 · zp930826