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

Intracranial Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158087
• Other study ID #: TP-1319
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2023
• Est. completion date: June 20, 2026

Study information

• Verified date: November 2023
• Source: Shanghai Wallaby Medical Technologies Co.,Inc.
• Contact: Wenwen Jia
• Phone: +86 18818201005
• Email: wendy.jia[@]wallabyphenox.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 20, 2026
• Est. primary completion date: February 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• pEGASUS Stent System
Endovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Wallaby Medical Technologies Co.,Inc.	Phenox GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography	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.	6 months
Primary	Rate of major ipsilateral stroke or neurological death	Any major ipsilateral stroke or neurological death	12 months
Secondary	Technical success rate	Technical success is defined as the successful placement of pEGASUS stent system.	Within 24 hours after surgery
Secondary	Rate of successful occlusion	Aneurysm successful occlusion is defined as Raymond Grade I/II.	Within 24 hours after surgery, 6 months, 12 months
Secondary	Rate of complete occlusion	Aneurysm complete occlusion is defined as Raymond Grade I.	Within 24 hours after surgery, 6 months, 12 months
Secondary	Rate of good clinical prognosis	Good clinical prognosis means mRS 0~2	3 months, 6 months, 12 months
Secondary	Death, stroke, and thrombotic events	Record the number of death, stroke and thrombotic events throughout the clinical trial period.	to 12 months