Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Internal decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this observational post-marketing registry will be to collect and analyze safety, effectiveness, and quality of life outcomes, during and after treatment with the Surpass Flow Diverter. Health Economics assessments (cost data) will also be collected and analyzed.
This will be a prospective, observational, multi-center, single-arm, post-marketing, international registry with consecutive enrollment of a minimum of 150 patients treated with the Surpass Flow Diverter in accordance with the standard of care at up to 30 registry sites.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group; Surpass Flow Diverter(s) | Individuals using the Surpass Flow Diverter(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surpass Flow Diverter(s) | Device | Endovascular placement of a Surpass Flow Diverter(s) for the treatment of an intracranial aneurysm(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary effectiveness based on the proportion of patients with 100% aneurysm occlusion | The proportion of patients with 100% aneurysm occlusion, based on an assessment of each patient's imaging at 12 months (± 180 days) post-procedure, and stratified across four aneurysm categories. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success assessed by deployment of the device with complete coverage of the aneurysm neck | Successful deployment of the device with complete coverage of the aneurysm neck. | Peri-procedural |
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcomes assessed by neurological adverse events | Neurological adverse events | Up to 5 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
For the primary endpoint, the evaluable patient population will consist of all individuals treated with the Surpass Flow Diverter(s) who have provided consent, and who have completed their 12 month follow-up assessment.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Patrick A Brouwer, MD | Karolinska Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ groeninge | Kortrijk | 8500 | Belgium | |||
| Helsinki University Hospital |
Not provided
Not provided
Not provided
Not provided
| Helsinki |
| 00260 |
| Finland |
| Turun yliopistollinen keskussairaala | Turku | 20521 | Finland |
| Hopital Jean Minjoz | Besançon | 25030 | France |
| APHP - Kremlin Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| Fondation Rothschild | Paris | 75020 | France |
| Hopital Bretonneau | Tours | 37 000 | France |
| Freiburg University Hospital | Freiburg im Breisgau | 79085 | Germany |
| Klinikum Kassel | Kassel | 34125 | Germany |
| Universitätsmedizin Mannheim | Mannheim | 68167 | Germany |
| San Martino Hospital | Genova | 16132 | Italy |
| Neuroradiologia Azienda ILSS9 | Treviso | 31100 | Italy |
| Radboudumc | Nijmegen | 6500 | Netherlands |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Karolinska University Hospital in Solna, Department of Neuroradiology | Stockholm | 171 16 | Sweden |
| Queen's Hospital of Romford, NHS Barking, Havering and Redbridge University Hospitals Trust | Romford | Essex | RM7 0AG | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | United Kingdom |
| The Walton center | Liverpool | L9 7LJ | United Kingdom |
| 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 |
Not provided
Not provided