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

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457479
• Other study ID #: HYBRID
• Status: Completed
• Start date: November 2, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Acandis GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 30, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Germany	Evangelisches Krankenhaus Oldenburg	Oldenburg

Sponsors (1)

Lead Sponsor	Collaborator
Acandis GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	mTICI = 2b after treatment with APERIO® HYBRID(17/21)	until 24 hours after intervention
Primary	Good clinical outcome at 90 days	Modified Rankin Scale (mRS) < 3 (mRS 1= no symptoms/ good outcome; mRS 6= Patient died/ worse outcome)	90 days after intervention
Primary	Periprocural symptomatic intracranial hemorrhage (sICH):	ICH in postinterventional (<24 hours) CT associated with worsening of NIHSS by = 4 points within 24 hours	until 24 hours after intervention
Secondary	Cerebrovascular events until hospital discharge:	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	between 24 hours after intervention and discharge from hospital
Secondary	Cerebrovascular events at 90 days	Intracranial haemorrhage (symptomatic / asymptomatic); Death; TIA; Non-disabling ischemic stroke (MRS 0-2); Disabling ischemic stroke (MRS 3-6)	at 90 days