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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.). | assessed at 6 months after procedure |
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Inclusion Criteria:
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:
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The target population for this prospective registry includes patients with unruptured intracranial aneurysms suitable for Pipeline Flex with Shield at the operators' discretion.All patients underwent thromboelastography and CYP2C19 genotyping.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |