REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®

Acute Stroke Clinical Trial

Official title:

REcanalization of Distal Cerebral Vessels In Acute Stroke Using ApeRio®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04479020
• Other study ID #: REVISAR Revision 4.0
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: January 2024

Study information

• Verified date: May 2023
• Source: Acandis GmbH
• Contact: Franziska Dorn, Prof. Dr. med.
• Phone: +49 (0) 228-287-16505
• Email: Franziska.Dorn[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

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)

Locations

Country	Name	City	State
Germany	Schlosspark Klinik Charlottenburg	Berlin
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Klinikum Fulda gAG	Fulda
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Universitätsklinikum Köln	Köln
Germany	Universitätsklinikum Magdeburg A. ö. R.	Magdeburg
Germany	Johannes Wesling Klinikum Minden	Minden
Germany	Klinikum der Universität München	München
Germany	radprax Neurozentrum Solingen	Solingen

Sponsors (1)

Lead Sponsor	Collaborator
Acandis GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediatley after interventional procedure
Primary	Primary safety endpoint	• Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (<48 hours) CT associated with worsening of NIHSS by = 4 points within 48 hours.	48 hours
Primary	Primary safety endpoint	Rates of device and procedure related (serious) adverse events ((S)AEs)	90 days
Primary	Primary Safety endpoint	Mortality	90 days
Secondary	Good neurological outcome	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	90 days