REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®

NCT04479020 | Completed

• 1 other identifier: REVISAR Revision 4.0
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 11

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.

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (4)

• 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 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 safety endpoint

  Rates of device and procedure related (serious) adverse events ((S)AEs)

  90 days

• Primary Safety endpoint

  Mortality

  90 days

Secondary Outcomes (1)

• Good neurological outcome

  90 days

Interventions

Mechanical Thrombectomy DEVICE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• pre stroke mRS ≥ 3
• Any contraindication according to IFU

Sponsors & Collaborators

• Acandis GmbH: lead

Study Sites (11)

Schlosspark Klinik Charlottenburg

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Köln

Cologne, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Klinikum Fulda gAG

Fulda, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Germany

Location

Universitätsklinikum Magdeburg A. ö. R.

Magdeburg, Germany

Location

Johannes Wesling Klinikum Minden

Minden, Germany

Location

Klinikum der Universität München

München, 80336, Germany

Location

radprax Neurozentrum Solingen

Solingen, 42697, Germany

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 21, 2020
• Study Start: July 1, 2020
• Primary Completion: January 30, 2024
• Study Completion: May 1, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

DE (11)