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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01079-32 | Other Identifier | IDRCB |
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Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique has recently been developed, using flow diverter stents without associated coils. Clinical results already published are encouraging but have to be confirmed. Furthermore, these medical devices are expensive in comparison to the coiling strategy. The purpose of this study is to compare the clinical efficacy, safety, and cost-effectiveness of endovascular coiling and endovascular flow diversion for unrupted saccular intracranial aneurysms.
Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovascular intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PIPELINE flow diverter stent | Experimental | flow diverter stent |
|
| Coils, with or without expendable stent | Active Comparator | Coils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIPELINE flow diverter stent | Device | endovascular procedure using the medical device PIPELINE |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with complete occlusion of the treated aneurysm, defined as the absence of visible blood flow on angiography performed 12 months after endovascular procedure. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a death during or after endovascular procedure | hospitalization for the endovascular procedure, up to 7 days | |
| Occurrence of a death whatever the cause | 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis TURJMAN, PH | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Lyon | BRON | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25280445 | Result | Turjman F, Levrier O, Combaz X, Bonafe A, Biondi A, Desal H, Bracard S, Mounayer C, Riva R, Chapuis F, Huot L, Armoiry X, Gory B. EVIDENCE trial: design of a phase 2, randomized, controlled, multicenter study comparing flow diversion and traditional endovascular strategy in unruptured saccular wide-necked intracranial aneurysms. Neuroradiology. 2015 Jan;57(1):49-54. doi: 10.1007/s00234-014-1439-7. Epub 2014 Oct 4. |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Coils, with or without expendable stent | Device | endovascular embolization procedure using microspires, with the possibility of using a balloon temporary and / or implantation of a stent complementary intracranial before implementation of microspires |
|
| Occurrence of a death due to aneurysm rupture |
| 24 months |
| Occurrence of an intracranial hemorrhagic from rupture of the aneurysm | 24 months |
| Occurrence of an ischemic stroke due to thrombosis | 24 months |
| Occurrence of a non-cerebral bleeding | 24 months |
| Rate of patients with neurological deficits by mass effect | hospitalization for the endovascular procedure, an expected average of 1 hour; 3 months, 6 months and 12 months post-intervention |
| Retreatment of the aneurysm | 24 months |
| Rate of technical complications | Endovascular procedure an expected average of 1 hour |
| Rate of thromboembolic complications, intraoperative ruptures, complications at the puncture site, or others | Endovascular procedure an expected average of 1 hour |
| Rate of correct placement of flow diverter stents, according to the investigator | Endovascular procedure an expected average of 1 hour |
| mean duration of irradiation related to angiography | Endovascular procedure an expected average of 1 hour |
| Rate of patients for each class of occlusion | The classes of occlusion are defined as : complete occlusion, residual neck, residual aneurysm, for the group treated with coiling procedure; grades 0 to 4 according to the scale of Kamran, for the group treated with flow diversion | Endovascular procedure , an expected average of 1 hour and 12 months |
| Modified Rankin score | Inclusion, 3 months and 12 months |
| National Institute of Health Stroke Score (NIHSS) | Inclusion, 3 months and 12 months |
| Evolution of the Barthel index | : Inclusion and 12 months |
| Incremental cost-effectiveness ratio | 12 months |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |