To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Wallaby Medical Technologies Co.,Inc.

About this trial

The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.

Eligibility criteria

Qualifiers

Aged from 18 to 80 years, male or female;

Patients diagnosed as wide-neck intracranial aneurysms by brain CTA/MRA/DSA (neck width≥4mm or bodyor a dome-to-neck ratio<2);

Parent vessel with a diameter of ≥2.5mm and ≤4.5mm;

Patients target aneurysm is planned to be embolized using intracranial stent assisted with coiling;

Disqualifiers

Patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment.

Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography.

Known to be allergic to Nitinol platinum alloy and angiographic agents.

Conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation.

Trial design

Treatments tested in this trial

  • pEGASUS Stent System

Treatment groups

130 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shanghai Wallaby Medical Technologies Co.,Inc.

Lead sponsor

Phenox GmbH

Collaborator

Beijing Wallaby Medical Technologies Co.,Inc.

Collaborator