Status:
RECRUITING
To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms
Lead Sponsor:
Shanghai Wallaby Medical Technologies Co.,Inc.
Collaborating Sponsors:
Phenox GmbH
Beijing Wallaby Medical Technologies Co.,Inc.
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18-80 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 20 2026
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06158087
Start Date
December 29 2023
End Date
June 20 2026
Last Update
June 27 2024
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 222018