I67.10
Conditions
Interventions
Group 1: Observation group:
Patients with intracranial Aneurysms scheduled for endovascular treatment and need for stent reconstruction of the parent vessel for coiling
Sponsors
Acandis GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Candidates for this Study must meet all of the following criteria to be enrolled in the Study. The information will be recorded on the Inclusion/Exclusion Criteria Case Report Form (CRF). • Subjects with unruptured saccular intracranial aneurysms. • Wide neck or other indication justifying stent reconstruction of parent vessel for coiling. • Maximal aneurysm diameter between 2 and 20 mm • Normal arterial diameter adjacent to the aneurysm diameter 18 years and < 80 years • Has been informed of the nature of the study, agrees to its provisions and provided written (or witnessed verbal) informed consent; which was approved by the appropriate Ethics Committee (EC) of the respective clinical site
Exclusion criteria
Exclusion criteria: Candidates will be ineligible for enrollment in the study if any of the following conditions apply. The information will be recorded on the Inclusion/Exclusion Criteria CRF. • Subjects with giant aneurysms > 20 mm in size • Fusiform aneurysms without any unilateral sac. • Acute dissections or peripheral aneurysms beyond second order intracranial arteries. • Subjects with subarachnoid hemorrhage • Subjects with major disability (mRS > 2) • Subjects who are unable to give informed consent without legal assistance • Subjects with contraindications for placement and delivery of selfexpanding stents (e.g., extreme tortuosity, other access problems) • Subjects with contraindications or intolerance of double antiplatelet therapy with Clopidogrel and Aspirin. • Known allergic reaction against nitinol alloys • Hemoglobin level < 10 g/dL • Platelet count < 100,000 • Un-correctable bleeding diathesis • Subjects with progressive or unstable neurological deficits • Subjects with indications for oral anticoagulation • Co-morbidity (f. e. malignant tumors, major strokes, renal insufficiency) with reduced life expectancy of less than one year or significantly increased risk during stent-assisted coiling • Protocol non-compliance or logistics that would limit follow-up (e.g., Subject lives far from site, substance abuse, psychosocial issues, etc.) • Women who are pregnant or plan to become pregnant during the study • Subjects enrolled in any concurrent study, without written approval from Acandis that may confound the results of this Study • Previous endovascular stents at the same aneurysm • Embolization of the aneurysm with liquid embolic agents or other materials different from bare or coated platinum coils. • High–grade stenosis or vessel deformity in the vessel territory planed to be treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical Feasibility: •Successful access to the site of the aneurysm with the Acandis® Neuroclosed delivery catheter system •Exact stent placement across the neck of the aneurysm •Successful microcatheter access to the aneurysm through the stent filaments and coiling of the aneurysm Safety: •Rate of procedure or device related adverse events with new neurologic deficits during the first 30 days and after 6 months •Procedure related stroke, intracranial hemorrhage and death | — |
Secondary
| Measure | Time frame |
|---|---|
| Angiographic Results • Patency of the parent vessel after the procedure and after 6 months. • Stent apposition to the vessel wall • Occlusion of the aneurysm according to Raymond classification after the procedure and after 6 months • Rate of in-stent-stenosis after 6 months Technical and Clinical Results • Rate of clinically silent complications • Stent misplacement or dislodgement • Coil protrusion into stent • Proc. related thrombembolic complications • Clinical silent perforations • Clinical outcome according to mRS after 30 days and 6 months | — |
Countries
Germany
Contacts
Public ContactKarl Beck
Acandis GmbH & Co. KG
Outcome results
None listed