Clinical trial NCT06158087: To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Shanghai Wallaby Medical Technologies Co.,Inc.
Sponsor class: INDUSTRY
Collaborators: name: Phenox GmbH
name: Beijing Wallaby Medical Technologies Co.,Inc.
First posted: 2023-12-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Aneurysm Occlusion of the Treated Target Lesion on 6 Month Angiography
timeFrame: 6 months
measure: Rate of major ipsilateral stroke or neurological death
timeFrame: 12 months
Secondary outcomes:
measure: Technical success rate
timeFrame: Within 24 hours after surgery
measure: Rate of successful occlusion
timeFrame: Within 24 hours after surgery, 6 months, 12 months
measure: Rate of complete occlusion
timeFrame: Within 24 hours after surgery, 6 months, 12 months
measure: Rate of good clinical prognosis
timeFrame: 3 months, 6 months, 12 months
measure: Death, stroke, and thrombotic events
timeFrame: to 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
References: