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NCT Number: NCT06474884

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

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.

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Key information

Conditions

Treatment Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Aneurysm Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with unruptured intracranial aneurysms who received the intracranial Pipeline Flex with Shield stent.
  • Vascular conditions:
  • 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.

Treatment and study plan

Primary outcomes

  1. Rate of complete aneurysm occlusion in 6 months

    Time frame: 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.

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

    Time frame: 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.).

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jun 26, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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