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

Not Applicable

Recruiting

• Conditions: Intracranial Aneurysm
• Interventions: Device: pEGASUS Stent System

• Registration Number: NCT06158087
• Lead Sponsor: Shanghai Wallaby Medical Technologies Co.,Inc.

Brief Summary

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

Detailed Description

Title: A prospective, multicenter, single-arm clinical trial to evaluate the safety and efficacy of pEGASUS stent system for assisted endovascular treatment of intracranial aneurysms Device: pEGASUS stent system Design: Prospective, Multicenter, Single Arm Clinical Study. Purpose: To assess safety and effectiveness of the pEGASUS stent system. Study duration: 31 months. Sample Size: 130 patients. Number of sites: ≤10. Follow-up time: 12 months.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Study Start: 2023-12-29
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2026-02-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test group	pEGASUS Stent System	Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent, intent to use pEGASUS stent system assisted to treat intracranial aneurysm.

Primary Outcome Measures

Name	Time	Method
Rate of major ipsilateral stroke or neurological death	12 months	Any major ipsilateral stroke or neurological death
Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography	6 months	Complete aneurysm occlusion (100% occlusion - Raymond Class 1) of the treated target lesion on 6 month angiography, in the absence of retreatment, or parent artery stenosis (\> 50%) at the target location.

Secondary Outcome Measures

Name	Time	Method
Technical success rate	Within 24 hours after surgery	Technical success is defined as the successful placement of pEGASUS stent system.
Rate of complete occlusion	Within 24 hours after surgery, 6 months, 12 months	Aneurysm complete occlusion is defined as Raymond Grade I.
Rate of successful occlusion	Within 24 hours after surgery, 6 months, 12 months	Aneurysm successful occlusion is defined as Raymond Grade I/II.
Death, stroke, and thrombotic events	to 12 months	Record the number of death, stroke and thrombotic events throughout the clinical trial period.
Rate of good clinical prognosis	3 months, 6 months, 12 months	Good clinical prognosis means mRS 0\~2

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China