Phase
Condition
Aneurysm
Treatment
pEGASUS Stent System
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged from 18 to 80 years, male or female;
Patients diagnosed as wide-neck intracranial aneurysms by brain CTA/MRA/DSA (neckwidth≥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 stentassisted with coiling;
The mRS Score of the patients was 0-2;
Patients understand the purpose of the study, accept the follow-up period, and agreeto comply with all requirements, agree to participate in the clinical trial andvoluntarily sign the informed consent.
Exclusion
Exclusion Criteria:
Patients who have contraindications to antiplatelet and/or anticoagulant therapy ordo not start antiplatelet therapy in time before treatment.
Patients with anatomical structure is not suitable for endovascular treatment due tosevere 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 fromcompleting the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrialfibrillation.
Patients combined moyamoya disease, intracranial tumor, intracranial arteriovenousmalformation, intracranial arteriovenous fistula and intracranial hematoma.
The target aneurysm has previously received intravascular embolization or stentimplantation 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 duringthe study period;
Participation in any other clinical trial within 30 days prior to signing informedconsent;
Other conditions considered by the investigator to be inappropriate for enrollment.
Study Design
Study Description
Connect with a study center
Changhai Hospital
Shanghai, Shanghai 222018
ChinaActive - Recruiting

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