REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®
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ClinicalTrials.gov Identifier: NCT04479020 |
Recruitment Status :
Recruiting
First Posted : July 21, 2020
Last Update Posted : June 29, 2021
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Condition or disease | Intervention/treatment |
---|---|
Acute Stroke | Device: Mechanical Thrombectomy |
Study Type: prospective, multicenter, single-arm, open-label Participants: 10 participating centers in Germany planned 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 inin 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.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 130 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Months |
Official Title: | REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio® |
Actual Study Start Date : | July 1, 2020 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | January 2022 |

- Device: Mechanical 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)
- Primary efficacy endpoint [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 90 days ]Rates of device and procedure related (serious) adverse events ((S)AEs)
- Primary Safety endpoint [ Time Frame: 90 days ]Mortality
- Good neurological outcome [ Time Frame: 90 days ]
mRS (modified Ranking Scale)= 0-2
0 No Symptoms
- No significant disability, despite symptoms, able to perform all usual duties and activities
- Slight disability; unable to perform all previous activities but able to look after own affairs without assistance
- Moderate disability; requires some help, but able to walk without assistance
- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance
- Severe disability bedridden incontinent and requires constant nursing care and attention
- Patient died

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479020
Contact: Franziska Dorn, Prof. Dr. med. | +49 (0) 228-287-16505 | Franziska.Dorn@ukbonn.de |
Germany | |
Schlosspark Klinik Charlottenburg | Recruiting |
Berlin, Germany | |
Contact: Annette Förschler, Dr. med. | |
Universitätsklinikum Bonn | Recruiting |
Bonn, Germany, 53127 | |
Contact: Franziska Dorn, Prof. Dr. med. | |
Universitätsklinikum Düsseldorf | Recruiting |
Düsseldorf, Germany | |
Contact: Bernd Turowski, Prof. Dr. | |
Klinikum Fulda gAG | Recruiting |
Fulda, Germany | |
Contact: Kallenberg Kai, PD. Dr. | |
Universitätsmedizin Göttingen | Recruiting |
Göttingen, Germany | |
Contact: Marielle Ernst, PD Dr. med. | |
Universitätsklinikum Köln | Recruiting |
Köln, Germany | |
Contact: Christoph Kabbasch, Dr. | |
Universitätsklinikum Magdeburg A. ö. R. | Recruiting |
Magdeburg, Germany | |
Contact: Daniel Behme, PD. Dr. med. | |
Johannes Wesling Klinikum Minden | Recruiting |
Minden, Germany | |
Contact: Borggrefe Jan, Prof. Dr. med. | |
Klinikum der Universität München | Recruiting |
München, Germany, 80336 | |
Contact: Thomas Liebig, Prof.Dr. med. | |
radprax Neurozentrum Solingen | Recruiting |
Solingen, Germany, 42697 | |
Contact: Hannes Nordmeyer, Dr. med. |
Responsible Party: | Acandis GmbH |
ClinicalTrials.gov Identifier: | NCT04479020 |
Other Study ID Numbers: |
REVISAR Revision 3.2 |
First Posted: | July 21, 2020 Key Record Dates |
Last Update Posted: | June 29, 2021 |
Last Verified: | June 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |