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

NCT06474884 | Recruiting

• 1 other identifier: zp930826
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment

Keywords

intracranial aneurysm

Outcome Measures

Primary Outcomes (2)

• Rate of complete aneurysm occlusion in 6 months

  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.

  assessed at 6 months after procedure

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

  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.).

  assessed at 6 months after procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• According to the committee's assessment, only one Pipeline flex with shield is needed for aneurysm treatment.
• Before the stent implantation procedure, standard dual antiplatelet therapy should be administered for at least 3 days.
• Patients with an Modified Rankin Scale(mRS) score of less than 2 on the day of registration.
• The operation was successful, and immediate postoperative angiography indicated good wall apposition.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)