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

Launched by SHANGHAI WALLABY MEDICAL TECHNOLOGIES CO.,INC. · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment method for patients with wide-neck intracranial aneurysms, which are bulges in blood vessels in the brain that can be dangerous. The main goal is to evaluate the safety and effectiveness of a device called the pEGASUS stent system, which is used to help close off the aneurysm and prevent it from rupturing. Researchers are currently recruiting participants aged 18 to 80 who have specific types of aneurysms and are in relatively good health, as indicated by a certain scoring system.

If you or a loved one are considering participation, you would need to meet specific health criteria, such as not having any serious heart or blood conditions and being able to understand the study's purpose. Participants will undergo the stent procedure and will have follow-up appointments to monitor their health and ensure the treatment is working. It’s important to know that there are several conditions that could prevent someone from joining this trial, including certain health issues and previous treatments for aneurysms. Overall, this study aims to find a safe and effective way to treat this serious condition, providing hope for better management of intracranial aneurysms.

Gender

ALL

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.