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

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

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

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenwen Jia; Phone Number: +86 18818201005; Email: wendy.jia@wallabyphenox.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 222018
      • Recruiting
      • Changhai Hospital
      • Contact: Jianmin Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group; 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.	Device: pEGASUS Stent System; Endovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rate of major ipsilateral stroke or neurological death	Any major ipsilateral stroke or neurological death	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Wallaby Medical Technologies Co.,Inc.
• Collaborators: Phenox GmbH; Beijing Wallaby Medical Technologies Co.,Inc.
• Investigators: Principal Investigator: Jianmin Liu, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2023
• Primary Completion (Estimated): February 20, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: TP-1319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No