Intracranial Aneurysm Clinical Trial
— NuCATCHOfficial title:
A Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Trial of Bioabsorbable/Nufairy Coil Embolization System for the Treatment of Intracranial Aneurysms
Verified date | June 2024 |
Source | MicroPort NeuroTech Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.
Status | Active, not recruiting |
Enrollment | 258 |
Est. completion date | June 1, 2026 |
Est. primary completion date | October 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Male or female =18 years old and =80 years old at the time of signing the informed consent; 2. Intracranial aneurysm diagnosed by CTA, MRA, DSA neuroimaging examination; 3. Subjects whose target aneurysms are suitable for embolization with flow diverter or intracranial arterial stents assisted by coils, and the entire treatment can be performed in a single procedure; 4. The subjects or the subject's guardian signs the informed consent voluntarily and is willing to accept follow-up. Exclusion Criteria: 1. mRS Score =3 points in clinical assessment prior to enrollment; 2. Subjects who received neurosurgical or endovascular treatment for recurrent aneurysms; 3. Subjects with multiple aneurysms; 4. Subjects with ruptured aneurysms <30 days; 5. Significant stenosis (=50%) of parent artery; 6. Subjects who are not suitable for anesthesia or intravascular surgery, such as major diseases of the heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, and a history of serious mental illness; 7. Subjects who have undergone major surgical procedures (such as internal fixation device implantation of limbs fracture, tumor resection, major organ surgery, etc.) within 30 days before signing the informed consent or plan to undergo major surgical procedures within 60 days after signing the informed consent; 8. Subjects with morphology or lesions that may interfere with device use, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, limited vascular access (e.g., severe intracranial vessel tortuosity, severe intracranial vessel spasm that does not respond to medical treatment, other anatomical or clinical changes that impede device access; 9. Treatment contrainidations of coils, including but not limited to: contrainidations of digital subtraction angiography, allergy to or intolerance of contrast agents, allergy to or intolerance of anti-platelet and anticoagulant drugs required for treatment, platinum-tungsten alloy, and poly(co-glycolic acid) (PLGA); 10. Pregnant or lactating women; 11. Life expectancy is less than 18 months; 12. Subjects participating in other drug or device studies did not meet the endpoint. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Changhai Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
MicroPort NeuroTech Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Successful occlusion rate of aneurysm at 18-month post-procedure. | It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization). | 18 month | |
Other | Recurrence rate of aneurysm at 18-month post-procedure. | The "recurrence rate of aneurysm" was defined as the percentage of subjects with a decrease in the degree of aneurysm embolization at the follow-up visit as compared with immediately post-procedure. | 18 month | |
Other | Retreatment rate of aneurysm at 18-month post-procedure. | The "retreatment of aneurysm" was defined as the percentage of subject who received retreatment for the recurrence of target aneurysms during the follow-up period | 18 month | |
Other | The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 18 months. | 18 month | ||
Other | Device-related serious adverse events at 18 months after surgery | 18 month | ||
Primary | Successful occlusion rate of aneurysm at 12-month post-procedure. | It was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I or II (i.e., 95%-100% aneurysm embolization). | 12 month | |
Secondary | Complete occlusion rate of aneurysm at 12-month post-procedure. | The "complete occlusion rate of aneurysm" was defined as the percentage of subjects with the degree of aneurysm embolization scored as Raymond I (i.e., 100% aneurysm embolization). | 12 month | |
Secondary | Recurrence rate of aneurysm at 12-month post-procedure. | The "recurrence rate of aneurysm" was defined as the percentage of subjects with a decrease in the degree of aneurysm embolization at the follow-up visit as compared with immediately post-procedure. | 12 month | |
Secondary | Retreatment rate of aneurysm at 12-month post-procedure. | The "retreatment of aneurysm" was defined as the percentage of subject who received retreatment for the recurrence of target aneurysms during the follow-up period | 12 month | |
Secondary | Device-related serious adverse events at 1, 6, and 12 months after surgery; | 12 month | ||
Secondary | The incidence of ipsilateral stroke or neurologic death of the target aneurysm within 12 months. | 12 month | ||
Secondary | The incidence of ipsilateral ischemic stroke of the target aneurysm within 12 months. | 12 month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04870047 -
Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
|
N/A | |
Recruiting |
NCT05968053 -
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
|
||
Not yet recruiting |
NCT05665309 -
Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
|
N/A | |
Completed |
NCT02783339 -
Neuroform Atlas Stent for Intracranial Aneurysm Treatment
|
||
Withdrawn |
NCT01194388 -
Axium Coil in Completing Endovascular Aneurysm Surgery Study
|
||
Completed |
NCT00071565 -
Familial Intracranial Aneurysm Study II
|
N/A | |
Recruiting |
NCT05409989 -
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
|
N/A | |
Completed |
NCT03680742 -
Contour Neurovascular System - European Pre-Market Unruptured Aneurysm
|
N/A | |
Completed |
NCT04872842 -
Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
|
||
Terminated |
NCT02532517 -
Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
|
N/A | |
Completed |
NCT03663257 -
Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
|
||
Recruiting |
NCT06189950 -
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE
|
N/A | |
Recruiting |
NCT05608122 -
Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)
|
||
Recruiting |
NCT03661463 -
Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT).
|
Phase 2 | |
Completed |
NCT02609867 -
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
|
N/A | |
Active, not recruiting |
NCT02292017 -
Prospective Packing Density With Target Coils I
|
N/A | |
Active, not recruiting |
NCT01872741 -
Minipterional Versus Pterional Craniotomy
|
N/A | |
Completed |
NCT00993057 -
Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia
|
Early Phase 1 | |
Completed |
NCT00777907 -
Complete Occlusion of Coilable Aneurysms
|
Phase 3 | |
Completed |
NCT00777088 -
Pipeline for Uncoilable or Failed Aneurysms
|
N/A |