Clinical trial NCT06474884: The Safety and Efficacy of Single Antiplatelet Therapy After Pipeline Flex with Shield for Intracranial Aneurysms
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Treatment
Keywords: intracranial aneurysm
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

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.

Primary outcomes:
measure: Rate of complete aneurysm occlusion in 6 months
timeFrame: assessed at 6 months after procedure
measure: Hemorrhagic, ischemic events, or neurological deficits occurring within 6 months postoperatively.
timeFrame: assessed at 6 months after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
References: