An observational study in Acute Stroke, sponsored by Acandis GmbH. Completed at 11 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by Acandis GmbH · Observational
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 134 is below the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Acandis GmbH is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with an APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to a thrombotic occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA).
Exclusion Criteria:
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)
Primary efficacy endpoint
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
Time frame: Immediatley after interventional procedure
Primary safety endpoint
• Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (\<48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours.
Time frame: 48 hours
Primary safety endpoint
Rates of device and procedure related (serious) adverse events ((S)AEs)
Time frame: 90 days
Primary Safety endpoint
Mortality
Time frame: 90 days
Good neurological outcome
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
Time frame: 90 days
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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