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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04457479

Enrollment

190

Registered

2020-07-07

Start date

2020-11-02

Completion date

2023-06-30

Last updated

2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Germany

Outcome results