Clinical trial NCT04479020: REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®
Official title: REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Stroke
Lead sponsor: Acandis GmbH
Sponsor class: INDUSTRY
First posted: 2020-07-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary efficacy endpoint
timeFrame: Immediatley after interventional procedure
measure: Primary safety endpoint
timeFrame: 48 hours
measure: Primary safety endpoint
timeFrame: 90 days
measure: Primary Safety endpoint
timeFrame: 90 days
Secondary outcomes:
measure: Good neurological outcome
timeFrame: 90 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Schlosspark Klinik Charlottenburg
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Fulda
country: Germany
facility: Klinikum Fulda gAG
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A. ö. R.
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
city: München
country: Germany
facility: Klinikum der Universität München
city: Solingen
country: Germany
facility: radprax Neurozentrum Solingen
Study officials:
References: