APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke

Completed

• Conditions: Acute Stroke

• Registration Number: NCT04457479
• Lead Sponsor: Acandis GmbH

Brief Summary

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® Hybrid(17/21) Thrombectomy Device in clinical practice. APERIO® Hybrid(17/21) Thrombectomy Device will be used within its approved indication.

Detailed Description

German APERIO® Hybrid Post- Market Clinical Follow-up Study

APERIO® Hybrid PMCF Study- Thrombectomy device for flow restoration in vessels of patients experiencing acute ischemic stroke

Study Type: prospective, multicenter, single-armed, open-label

Participants: 8 participating centers in Germany

PI: Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany

Estimated Enrolment: 190 patients treated with APERIO® HYBRID(17/21) Thrombectomy Device as a result of an acute stroke

Follow up: 3 months

Estimated Final Assessment: Mid to End of 2023

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Study Start: 2020-11-02
• Primary Completion: 2023-01-16
• Study Completion: 2023-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• All patients treated with APERIO® HYBRID and/or APERIO® Hybrid(17/21) Thrombectomy Device as a result of an acute stroke.

Exclusion Criteria

• Patient age < 18 years
• Pre stroke mRS ≥ 3

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success	until 24 hours after intervention	mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)
Good clinical outcome at 90 days	90 days after intervention	Modified Rankin Scale (mRS) \< 3 (mRS 1= no symptoms/ good outcome; mRS 6= Patient died/ worse outcome)
Periprocural symptomatic intracranial hemorrhage (sICH):	until 24 hours after intervention	ICH in postinterventional (\<24 hours) CT associated with worsening of NIHSS by ≥ 4 points within 24 hours

Secondary Outcome Measures

Name	Time	Method
Cerebrovascular events until hospital discharge:	between 24 hours after intervention and discharge from hospital	* Intracranial haemorrhage (symptomatic / asymptomatic); * Death; * TIA in the region of the target vessel; * Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel; * Disabling ischemic stroke (MRS 3-6) in the region of the target vessel; * TIA outside the region of the target vessel; * Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel; * Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel
Cerebrovascular events at 90 days	at 90 days	* Intracranial haemorrhage (symptomatic / asymptomatic); * Death; * TIA; * Non-disabling ischemic stroke (MRS 0-2); * Disabling ischemic stroke (MRS 3-6)

Trial Locations

Locations (1)

Evangelisches Krankenhaus Oldenburg; 🇩🇪 Oldenburg, Germany