Acute Stroke
Conditions
Brief summary
The purpose of the REVISAR PMCF is to collect data in clinical practice of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device, which are intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Recanalization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in cerebral infarction) score.
Detailed description
Study Type: prospective, multicenter, single-arm, open-label, national Participants: 11 participating centers in Germany PI: Dr. Franziska Dorn, University Hospital Bonn, Germany Estimated Enrolment: A minimum of 130 patients treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to thrombotic occlusions in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) Follow up: 3 months Estimated Final Assessment: End of 2022 This is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical Follow-up Study to collect comprehensive information on technical and clinical success and safety of the use of APERIO® and APERIO® Hybrid(17) Thrombectomy Device in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA). Aperio® and Aperio® Hybrid(17) Thrombectomy Device will be used within its approved indication.
Interventions
DEVICEMechanical Thrombectomy
Mechanical thrombectomy requiring the use an APERIO® or APERIO® Hybrid(17) Thrombectomy device due to an thrombotic occlusion in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)
Sponsors
Acandis GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any patient treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) according to IFU * Age ≥ 18 years
Exclusion criteria
* pre stroke mRS ≥ 3 * Any contraindication according to IFU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary efficacy endpoint | Immediatley after interventional procedure | Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion |
| Primary safety endpoint | 48 hours | • Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (\<48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours. |
| Primary Safety endpoint | 90 days | Mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Good neurological outcome | 90 days | mRS (modified Ranking Scale)= 0-2 0 No Symptoms 1. No significant disability, despite symptoms, able to perform all usual duties and activities 2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance 3. Moderate disability; requires some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability bedridden incontinent and requires constant nursing care and attention 6. Patient died |
Countries
Germany
Outcome results
None listed