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The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
Prospective, multi-center, single-arm, post-market follow-up study conducted in Europe for the treatment of patients with saccular intracranial aneurysms.
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| Measure | Description | Time Frame |
|---|---|---|
| Safety primary outcome measure | The primary safety endpoint of this study is stroke-related neurologic death, or major ipsilateral or disabling stroke in the territory supplied by the treated artery, occurring within 12 months post-procedure as adjudicated by an independent Clinical Events Committee (CEC)
| 1 year (± 6 months) |
| Effectiveness primary outcome measure | The primary effectiveness endpoint of this study is adequate aneurysm occlusion without retreatment or significant parent artery stenosis (>50% stenosis). The determination of adequate aneurysm occlusion using Raymond-Roy classification will be made if either of the following criteria are met:
| 1 year (± 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety secondary outcome measure | The secondary safety endpoint of this study is any stroke event occurring through 12 months post-procedure where a stroke event is defined as: • Rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke (i.e., intraparenchymal hemorrhage [IPH], subarachnoid hemorrhage [SAH], subdural hemorrhage [SDH], epidural hemorrhage [EDH]) accompanied with radiological evidence. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with Trenza device
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Cognard, Pr | Hospital Purpan, Toulouse, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salzburg University Hopsital | Salzburg | Austria | ||||
| Helsinski University Hospital |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
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| 1 year (± 6 months) |
| Helsinki |
| Finland |
| Turun yliopistollinen keskussairaala | Turku | Finland |
| Bordeaux Hopsital | Bordeaux | France |
| Brest Hospital | Brest | France |
| HCL Lyon | Lyon | France |
| Montpellier Hospital | Montpellier | France |
| APHP Bicêtre | Paris | France |
| Purpan Hospital | Toulouse | France |
| Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH | Bochum | Germany |
| Asklepios Hospital Hamburg St. Georg | Hamburg | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | Germany |
| Besta hopsital | Milan | Italy |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Spain |
| Hospital Universitario 12 de octubre | Madrid | Spain |
| Queen Elizabeth Hospital Birmingham | Birmingham | United Kingdom |
| NHS Lothian | Edinburgh | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | United Kingdom |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |