Intracranial Aneurysms Clinical Trial
Official title:
Canadian Study on the Endovascular Treatment of Unruptured Intracranial Aneurysms Versus Surgical Treatment. A Randomized Comparison of Clinical and Angiographic Results of Intracranial Aneurysms
Purpose: Phase 1: (Pilot Phase) To compare the treatment efficacy of surgical clipping and endovascular coiling for unruptured intracranial aneurysms. To obtain better estimates of morbidity and mortality related to a surgical or endovascular treatment strategy at one year within the context of an RCT. To show that an RCT comparing the morbidity and mortality of a surgical management strategy to an endovascular management strategy is feasible. Phase 2: To compare the results of surgical and endovascular management strategies, in terms of: 1. Overall mortality and morbidity at 1 and 5 years. 2. The clinical efficacy and safety of a surgical or endovascular management strategy at 1 and 5 years Hypotheses: Phase 1 Hypotheses: 1. Surgical clipping of intradural, saccular, unruptured intracranial aneurysms is superior to endovascular management in terms of a lesser number of patients experiencing treatment failure. 2. An RCT comparing the clinical outcomes of a surgical versus endovascular management strategy is feasible. Phase 1 Primary End-points: • Treatment failure, hereby defined as having occurred when either: the intended initial modality (surgical or endovascular) fails to occlude the aneurysm, a "major" (saccular) angiographic aneurysm recurrence is found, or an intracranial hemorrhagic event occurs during the 1-year follow-up period. Phase 1 Secondary End-points: 1. Overall morbidity and mortality at one year. 2. Occurrence of morbidity (mRS >2) or mortality following treatment. 3. Occurrence of failure of aneurysm occlusion using the initial intended treatment modality. 4. Occurrence of a "major" (saccular) angiographic aneurysm recurrence. 5. Occurrence of an intracranial hemorrhage following treatment. 6. Peri-treatment hospitalization lasting more than 5 days 7. Discharge following treatment to a location other than home Treatment: Trial feasibility, or the capacity for patient recruitment, would require enrollment of at least 8 patients per actively recruiting center per year. Phase 2 Hypotheses: It may be too early to explicitly define the primary hypothesis of Phase 2, however, the intent of Phase 2 can be expressed as: 1. One management strategy is superior to the other in terms of clinical outcome at five years. 2. One management strategy is superior to the other in terms of clinical efficacy at five years.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02879175 -
Patients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms
|
||
Recruiting |
NCT06411418 -
Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm
|
N/A | |
Completed |
NCT02312856 -
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
|
N/A | |
Recruiting |
NCT01054391 -
Neurovascular Embolization Cover for Treatment of Intracranial Aneurysms and Carotid/Vertebrobasilar Fistulae
|
N/A | |
Completed |
NCT02657772 -
Ultra Coils From Start to Finish for the Endovascular Repair of Small Intracranial Aneurysms
|
||
Completed |
NCT01465841 -
Study of the Penumbra Coil 400 System to Treat Aneurysm
|
N/A | |
Enrolling by invitation |
NCT05453240 -
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
|
||
Completed |
NCT03550638 -
Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms
|
N/A | |
Terminated |
NCT02122133 -
CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
|
||
Completed |
NCT01541254 -
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
|
Phase 2/Phase 3 | |
Terminated |
NCT01320306 -
Intracranial Aneurysms and Cognitive Function
|
||
Recruiting |
NCT01084681 -
Efficacy Trial of Intracranial Aneurysm Treatment Using Two Different Endovascular Techniques
|
N/A | |
Completed |
NCT00396981 -
MAPS Trial: Matrix And Platinum Science
|
Phase 4 | |
Completed |
NCT02921711 -
TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
|
||
Recruiting |
NCT01031147 -
Contrast-free Magnetic Resonance Angiography (MRA) at 3.0 T for Intracranial Aneurysm Detection
|
N/A | |
Recruiting |
NCT05636124 -
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
|
N/A | |
Completed |
NCT02921698 -
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
|
||
Completed |
NCT01801007 -
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
|
N/A | |
Terminated |
NCT01974700 -
Seizure Prophylaxis in Aneurysm Repair
|
Phase 4 | |
Completed |
NCT01793792 -
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
|
N/A |