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

NCT ID: NCT06474884

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Treatment

Keywords

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intracranial aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Peng H Zhang, MD

Role: primary

Yongjie Ma, MD

Role: backup

Other Identifiers

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zp930826

Identifier Type: -

Identifier Source: org_study_id