NCT04457479

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

December 10, 2019

Last Update Submit

August 8, 2023

Conditions

Acute Stroke

Outcome Measures

Primary Outcomes (3)

  • Technical success

    mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)

    until 24 hours after intervention

  • 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

  • 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 Outcomes (2)

  • Cerebrovascular events until hospital discharge:

    between 24 hours after intervention and discharge from hospital

  • Cerebrovascular events at 90 days

    at 90 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with acute large vessel occlusion (stroke) treated with the APERIO® Hybrid(17/21) Thrombectomy Device.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelisches Krankenhaus Oldenburg

Oldenburg, 26122, Germany

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular 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

December 10, 2019

First Posted

July 7, 2020

Study Start

November 2, 2020

Primary Completion

January 16, 2023

Study Completion

June 30, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

DE(1)