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IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.
IMPACT is an international, prospective, observational, multicenter, non-randomized, post market study designed to provide ongoing safety and performance evaluation on implantable devices used for the treatment of intracranial aneurysms with an endovascular approach. Data collection will also include details on adjunctive and ancillary devices used.
In addition, to gaining safety and performance data, this study will provide clinical evidence that may assist physicians in selecting an appropriate device(s) while describing treatment options used to treat patients with intracranial aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evolve EU | Selected hospitals for participation |
| |
| Evolve FR | All hospitals in France using the device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment of intracranial aneurysms using a flow-diverting stent | Device | The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Performance Measure | Composite of 100% occlusion of the target aneurysm without significant parent artery stenosis per independent core lab assessment and with no target aneurysm retreatment | 12 months |
| Primary Safety Endpoint | Stroke-related neurological death or Disabling stroke in the target vessel territory as adjudicated by an independent Clinical Events Committee (CEC) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Performance Measures | Target aneurysm recanalization, Parent artery stenosis ≥ 50%, Target aneurysm retreatment, Target aneurysm occlusion status, Aneurysm size evaluation | Through 24 months |
| Secondary Safety Endpoints |
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Inclusion Criteria (Evolve EU and Evolve FR):
Exclusion Criteria for (Evolve EU and Evolve FR):
Additional Key Exclusion Criteria (Evolve EU only):
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Subjects who have an intracranial aneurysm that the physician intends to treat with a Stryker Neurovascular device(s).
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| Name | Affiliation | Role |
|---|---|---|
| Zsolt Kulcsár, PhD., MD | Universitätsspital Zürich, Klinik für Neuroradiologie | Principal Investigator |
| Jean-Christophe Gentric, PhD., MD | CHU Cavale Blanche Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Salzburg | Salzburg | Austria | ||||
| Helsinki University Hospital |
After completion of the 12-month primary endpoint report, and under the guidance of a physician lead publication committee, a multi-center abstract reporting the results will be prepared and may be presented at a major meeting(s). A multi-center publication may also be prepared for publication in a peer reviewed scientific journal.
After completion of the 12-month primary endpoint report
A final report will be completed describing the results of all pre-specified outcomes, including negative results. The Sponsor will ensure investigators and regulatory authorities will receive the information contained in the final report.
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Procedural and device related serious adverse events, Any key neurological event of interest
| Through 24 months |
| Helsinki |
| Finland |
| Turku University Hospital | Turku | Finland |
| CHU Amiens | Amiens | France |
| CHRU Besançon | Besançon | France |
| CHU Pellegrin Bordeaux | Bordeaux | France |
| CHU Cavale Blanche Brest | Brest | France |
| CHU Clermont-Ferrand | Clermont-Ferrand | France |
| Henri Mondor Créteil | Créteil | France |
| CHU la Tronche Grenoble | La Tronche | France |
| CHU Lille | Lille | France |
| CHU Bron-Lyon | Lyon | France |
| CHU la Timone Marseille | Marseille | France |
| CHU Montpellier | Montpellier | France |
| CHU Nancy | Nancy | France |
| Hospital Fondation Rothschild - Paris | Paris | France |
| La Pitié Salpétrière | Paris | France |
| NEURI, Kremlin Bicêtre | Paris | France |
| CHU Rennes | Rennes | France |
| CHU Charles Nicolle Rouen | Rouen | France |
| CHU Saint Etienne | Saint-Etienne | France |
| CHU Bretonneau Tours | Tours | France |
| Universitatsklinikum Augsburg A.o.R | Augsburg | Germany |
| University Hospital Knappschaftskrankenhaus Bochum | Bochum | Germany |
| AO Careggi Hospital | Florence | Italy |
| Ospedale Policlinico San Martino | Genova | Italy |
| Grande Ospedale Metropolitano Niguarda | Milan | Italy |
| Fondazione Policlinico Universitario A. Gemelli | Rome | Italy |
| Inselspital Bern | Bern | Switzerland |
| University Hospital of Zurich | Zurich | Switzerland |
| Queen Elizabeth Hospital | Birmingham | United Kingdom |
| NHS Lothian | Edinburgh | 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 |
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