Evaluating a new stent system for treating brain aneurysms

Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of pEGASUS Stent System for Assisted Endovascular Treatment of Intracranial Aneurysms

This study is testing a new stent system to see if it can safely and effectively treat wide-neck brain aneurysms in patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Wallaby Medical Technologies Co.,Inc. (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06158087 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the pEGASUS stent system in treating wide-neck intracranial aneurysms. It is a prospective, multicenter, single-arm study involving up to 130 patients across 10 sites, with a follow-up period of 12 months. Participants will undergo endovascular treatment using the pEGASUS stent system, which is designed to assist in the embolization of aneurysms. The study will monitor patient outcomes to determine the stent's efficacy and safety profile over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with diagnosed wide-neck intracranial aneurysms suitable for endovascular treatment.

Not a fit: Patients with contraindications to antiplatelet therapy or unsuitable anatomical structures for endovascular treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with wide-neck intracranial aneurysms.

How similar studies have performed: Other studies have shown promise with similar endovascular approaches, but the pEGASUS stent system represents a novel intervention.

Eligibility criteria

Inclusion Criteria:

* 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;
* The mRS Score of the patients was 0-2;
* Patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent.

Exclusion Criteria:

* 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.
* Patients combined moyamoya disease, intracranial tumor, intracranial arteriovenous malformation, intracranial arteriovenous fistula and intracranial hematoma.
* The target aneurysm has previously received intravascular embolization or stent implantation treatment;
* Multiple aneurysms or complex aneurysms;
* Patients with acute ruptured aneurysm;
* Serious infection is not controlled and is not suitable for operation;
* Patients who underwent major surgery or interventional therapy (such as brain, cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery;
* Obvious abnormal coagulation function or bleeding tendency;
* Combined with severe renal insufficiency, creatinine greater than or equal to 200umol/L; Patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or ALT more than 3 times the upper normal limit;
* Pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period;
* Participation in any other clinical trial within 30 days prior to signing informed consent;
* Other conditions considered by the investigator to be inappropriate for enrollment.

Where this trial is running

Shanghai, Shanghai Municipality

• Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jianmin Liu — Changhai Hospital
• Study coordinator: Wenwen Jia

Conditions Intracranial Aneurysm