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

Launched by XUANWU HOSPITAL, BEIJING · Jun 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of using a single medication to prevent blood clots after a special type of stent, called the Pipeline Flex with Shield, is placed in the brain to treat unruptured intracranial aneurysms. An aneurysm is a weak spot in a blood vessel that can expand and potentially cause serious problems. The goal is to see if taking one antiplatelet medication instead of two, as is commonly done, is just as safe and effective for patients after their stent procedure.

To participate in this trial, patients must be between 65 and 74 years old and have an unruptured aneurysm that meets specific criteria related to the blood vessel's condition. They should have received the Pipeline Flex with Shield stent and must have a good health status before the procedure. Participants can expect to undergo regular check-ups and monitoring as part of the study to ensure their safety and to evaluate how well the treatment works. It’s important for potential participants to know that certain conditions, such as having had previous treatments for aneurysms or certain blood disorders, may prevent them from joining the trial.

Gender

ALL

Eligibility criteria

• 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.