Evaluating single antiplatelet therapy after stent implantation for brain aneurysms

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

This study is testing whether taking one type of blood-thinning medication after getting a stent for brain aneurysms is safe and effective for patients with unruptured aneurysms.

Quick facts

• Study type: Observational
• Enrollment: 165 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06474884 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety and efficacy of single antiplatelet therapy following the implantation of the Pipeline Flex with Shield stent in patients with unruptured intracranial aneurysms. It is a single-center, prospective cohort study that will follow participants for a period of six months post-implantation. The study includes patients who meet specific vascular conditions and have a successful stent placement, while excluding those with recurrent aneurysms or irregularly shaped aneurysms.

Who should consider this trial

Good fit: Ideal candidates are patients with unruptured intracranial aneurysms who have undergone successful Pipeline Flex with Shield stent implantation.

Not a fit: Patients with recurrent aneurysms or those who have undergone previous interventional treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into safer and more effective treatment options for patients with intracranial aneurysms.

How similar studies have performed: While there may be studies on antiplatelet therapy in similar contexts, this specific approach with the Pipeline Flex with Shield stent is relatively novel.

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.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, China (RECRUITING)

Conditions: Treatment, intracranial aneurysm