A Prospective, Multicenter, Single arm, Open, Pivotal study to evaluate the safety and effectiveness of the 'FloWise Cerebral Flow Diverter' for the treatment of unruptured wide neck Aneurysm
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0005194
- Lead Sponsor
- TeaWoong Medical
- Brief Summary
¦ Effectiveness Outcome When evaluating FAS, 56 subjects (81.16%) succeeded in target aneurysm occlusion at 12 months, the primary effectiveness endpoints, and the 95% confidence interval was reported as 69.94, 89.57, and the P-value<0.0001 was found in the analysis using a one-sided binomial distribution test to confirm the superiority to the reference value (56.7%), indicating that the FloWise's effectiveness was proven. When evaluating PPS, 49 of 59 subjects (83.05%) succeeded in target aneurysm occlusion at the 12-month time point. The 95% confidence interval was reported as 71.03, 91.56, and similar results to the analysis conducted on FAS were observed. With a P-value of <0.0001 in both FAS and PPS target analyses, demonstrating the clinical efficacy of the FloWise. Subjects corresponding to the procedure's success, the secondary effectiveness endpoints, were reported in 69 of 69 subjects (100%) in FAS. Subjects with a 50% reduction in target intracranial aneurysm volume compared to baseline at 12 months after the FloWise procedure showed similar results, with 66 of 69 subjects (95.65%) in FAS and 57 of 59 subjects (96.61%) %) in PPS. In conclusion, the FloWise, the investigational device in this study, showed a good success rate of unruptured wide neck aneurysm occlusion, a high rate of procedure success, and a target intracranial aneurysm volume reduction of more than 50% at 12 months after the FloWise procedure, demonstrating its effectiveness in treating unruptured wide neck aneurysm. ¦ Safety Outcome A total of 82 adverse events (AEs) were reported in 40 of 70 subjects (57.14%) during the 12-month follow-up period after the FloWise procedure, with an average of 2.05 cases reported per subject. In 70 subjects enrolled in this study, 15 cases of adverse device events (ADE) were reported in 12 subjects (17.14%) up to 12 months after the investigational device procedure. In 70 subjects enrolled in this study, 7 cases of serious adverse event (SAE) were reported in 6 subjects (8.57%) during the 12-month follow-up period after the investigational device procedure. One subject was dropped out of this study due to ‘Cerebral hemorrhage’, a serious adverse event that occurred during the FloWise procedure. 3 cases of serious adverse device events (SADE) were reported in 3 subjects (4.29%) during the study. Cerebral hemorrhage, Temporary visual impairment, and Right visual field defect were reported in 1 subject (1.43%) each, and the causal relationship with the investigational device was reported as 'Probably related', ‘Possibly related’, and 'Unknown' respectively. More than 50% parent artery stenosis or occlusion was reported in 2 patients (2.94%) during the 12-month follow-up period after the investigational device procedure, and no newly developed neurological disorder of more than 3 points on the modified Rankin Scale, an ipsilateral stroke of 5 or more NIHSS, and 30-day death were reported. To sum up, when the results of the adverse events and safety endpoints during the 12-month follow-up period after the investigational device ‘FloWise’ procedure, laboratory tests, vital signs, and physical examination results are comprehensively evaluated, the investigational device FloWise was considered safe for use in the treatment of Unruptured wide neck aneurysm. ¦ Conclusion In conclusion, when the above effectiveness and safety results are comprehensively evaluated, ‘FloWise Cerebral Flow Diverter’, a Flow diverter for use in the treatment of Unruptured wide neck aneurysm, has demonstrated superiority over licensed products and has shown good safety results, so it is judged that it can be used clinically as a medical device for treating cerebral aneurysms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
Functional neurological state =2 mRS(modified Rankin Scale).
Unruptured wide-neck aneurysm in the internal carotid artery has
-a neck =4mm, or
-dome/neck ratio <2
Parent artery of aneurysm with diameter =3.25mm and =5.00mm.
Patient willing to provide written informed consent and comply with follow-up requirements.
Female of childbearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding.
Intracranial hemorrhage within 30 days.
Untreated ruptured intracranial aneurysm =1 intracranial aneurysm except the target one requires treatment within 12 months.
Immunosuppressive disease.
Active infectious disease.
Platelet count < 1,000,000 cells/mm3.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target aneurysm occlusion
- Secondary Outcome Measures
Name Time Method Procedure success rate;Success rate of volume reduction of 50% or more in the target intracranial aneurysm