Actively Recruiting
To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms
Led by Shanghai Wallaby Medical Technologies Co.,Inc. · Updated on 2024-06-27
130
Participants Needed
1
Research Sites
129 weeks
Total Duration
On this page
Sponsors
S
Shanghai Wallaby Medical Technologies Co.,Inc.
Lead Sponsor
P
Phenox GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.
CONDITIONS
Official Title
To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged from 18 to 80 years, male or female
- Diagnosed with wide-neck intracranial aneurysms by brain CTA, MRA, or DSA (neck width 64 mm or dome-to-neck ratio < 2)
- Parent vessel diameter between 2.5 mm and 4.5 mm
- Target aneurysm planned for embolization using intracranial stent assisted coiling
- Modified Rankin Scale (mRS) score of 0 to 2
- Understand study purpose, accept follow-up, agree to participate and sign informed consent
You will not qualify if you...
- Contraindication to antiplatelet or anticoagulant therapy or failure to start antiplatelet therapy before treatment
- Anatomical unsuitability for endovascular treatment due to severe vascular tortuosity or stenosis
- Known allergy to Nitinol platinum alloy or angiographic agents
- Conditions preventing study completion (e.g., expected survival < 1 year, high-risk cerebral thrombosis, heart failure, atrial fibrillation)
- Presence of moyamoya disease, intracranial tumor, arteriovenous malformation, fistula, or hematoma
- Previous intravascular embolization or stent treatment of target aneurysm
- Multiple or complex aneurysms
- Acute ruptured aneurysm
- Uncontrolled serious infection
- Major surgery or interventional therapy within 30 days before study
- Abnormal coagulation or bleeding tendency
- Severe renal insufficiency (creatinine 6 200 umol/L) or severe liver disease
- Pregnancy, lactation, or planning pregnancy during study
- Participation in another clinical trial within 30 days before consent
- Other conditions considered unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 222018
Actively Recruiting
Research Team
W
Wenwen Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here