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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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The objective of this study is to demonstrate the safety and efficacy of the eCLIPs™ products for the treatment of bifurcation aneurysms.
This study is a multicentre, open label, historically controlled, single-arm safety and efficacy study of the eCLIPs™ products in the management of bifurcated intracranial aneurysms at basilar tip and carotid terminus. Patients with basilar tip and carotid terminus aneurysms are not considered suitable for surgical treatment by the neurovascular community because of the poor outcome in these localizations. Patients included in the study will have saccular intracranial aneurysms that arise at or adjacent to a bifurcation, having a neck length of ≥ 4mm or have a dome:neck ratio <2. Efficacy will be measured as the proportion of aneurysms achieving complete occlusion (Raymond-Roy 1) at 12 months, while safety will be measured as the proportion of patients without a major stroke or non-accidental death within 30 days (procedural) and without a major ipsilateral stroke or neurological death between 31 days and 12 months. Additional endpoints will be evaluated and data collected to assess safety and collect information on the eCLIPs™ family of products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Implantation of an eCLIPs™ device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of an eCLIPs™ device | Procedure | Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete aneurysm occlusion with no recurrence or re-treatment | Percent of subjects with complete aneurysm occlusion with no recurrence or re-treatment | 12 months |
| Major stroke or non-accidental death within 30 days, or major ipsilateral stroke or neurological death between 31 days and 12 months | Percent of subjects with a major stroke or non-accidental death within 30 days or with a major ipsilateral stroke or neurological death between 31 days and 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Proportion of successful eCLIPs™ device implants at the target aneurysm | Immediately after the procedure |
| Complete aneurysm occlusion | Percent of subjects with complete aneurysm occlusion at 6 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphaël Blanc, MD | Hôpital Fondation Adolphe de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens | Amiens | France | ||||
| Groupe Hospitalier Pellegrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28798268 | Background | Fiorella D, Arthur AS, Chiacchierini R, Emery E, Molyneux A, Pierot L. How safe and effective are existing treatments for wide-necked bifurcation aneurysms? Literature-based objective performance criteria for safety and effectiveness. J Neurointerv Surg. 2017 Dec;9(12):1197-1201. doi: 10.1136/neurintsurg-2017-013223. Epub 2017 Aug 10. |
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| eCLIPs™ Electrolytic Bifurcation Systems | Device | Implantation of an eCLIPs™ device and coiling of the bifurcation aneurysm |
|
| 24 months |
| Complete and nearly complete aneurysm occlusion | Percent of subjects with complete and nearly complete aneurysm occlusion at 6, 12 and 24 months | 24 months |
| Major ipsilateral stroke or neurological death | Percent of subjects with a major ipsilateral stroke or neurological death | 24 months |
| Success of adjuvant coiling into aneurysm after successful eCLIPs™ implant | Proportion of subjects with procedural success for the ability to insert coils into the aneurysm beyond the successfully implanted eCLIPs™ device, and the eCLIPs™ device to satisfactorily retain coils | Immediately after the procedure |
| Modified Rankin Score | Percent of subjects experiencing deterioration of Rankin Score from baseline to 1 month, 6-month, 12-month, and 24-month follow-up | 24 months |
| Serious Adverse Device Effects | Percent of subjects experiencing Serious Adverse Device Effects at 1, 6, 12 and 24 months | 24 months |
| Unplanned aneurysm re-treatment | Percent of subjects having an unplanned aneurysm re-treatment within 12 or 24 months | 24 months |
| Device migration | Proportion of device migration at 12 and 24 months | 24 months |
| Artery stenosis | Measurement of artery stenosis by radiography at 6, 12 and 24 months | 24 months |
| Artery patency | Qualitative assessment of artery patency at 6, 12 and 24 months | 24 months |
| Bordeaux |
| France |
| CHRU de Brest - Hôpital Cavale Blanche | Brest | France |
| HCL - Hôpital Pierre Wertheimer | Bron | France |
| CHU de Caen Normandie | Caen | France |
| Hôpital Gabriel Montpied | Clermont-Ferrand | France |
| CH de Colmar - Hôpital Louis Pasteur | Colmar | France |
| Clinique des Cèdres | Cornebarrieu | France |
| AP-HP - HU Henri-Mondor | Créteil | France |
| Hôpital François Mitterrand | Dijon | France |
| CHU Grenoble Alpes | Grenoble | France |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France |
| CHU de Limoges | Limoges | France |
| Hôpital de La Timone | Marseille | France |
| Hôpital privé Clairval | Marseille | France |
| CHU de Montpellier - Hôpital Guy de Chauliac | Montpellier | France |
| CHRU de Nancy - Hôpital Central | Nancy | France |
| CHU de Nice - Hôpital Pasteur | Nice | France |
| AP-HP - HU Pitié-Salpêtrière - Charles Foix | Paris | France |
| CH Sainte-Anne | Paris | France |
| Hôpital Fondation Adolphe de Rothschild | Paris | France |
| CHU de Poitiers | Poitiers | France |
| CHRU de Rennes -Hôpital Pontchaillou | Rennes | France |
| CHU de Rouen | Rouen | France |
| CHU de Nantes - Hôpital Laennec | Saint-Herblain | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | France |
| CHI Toulon | Toulon | France |
| CHRU de Tours - Bretonneau | Tours | France |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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