Acute StrokeNCT04457479
APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke
An observational study of Acute Stroke, run by Acandis GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- 2 Nov 2020to 30 Jun 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with acute large vessel occlusion (stroke) treated with the APERIO® Hybrid(17/21) Thrombectomy Device.
Who may be able to join
- All patients treated with APERIO® HYBRID and/or APERIO® Hybrid(17/21) Thrombectomy Device as a result of an acute stroke.
Who cannot join
- Patient age < 18 years
- Pre stroke mRS ≥ 3
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Acute Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)
Measured: 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)
Measured: 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
Measured: until 24 hours after intervention
Secondary outcomes (2)
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
Measured: between 24 hours after intervention and discharge from hospital
Cerebrovascular events at 90 days
- Intracranial haemorrhage (symptomatic / asymptomatic)
- Death
- TIA
- Non-disabling ischemic stroke (MRS 0-2)
- Disabling ischemic stroke (MRS 3-6)
Measured: at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start2 Nov 2020
- Primary completion16 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457479
- Sponsor's protocol ID
- HYBRID
- Status last verified
- Aug 2023
- First submitted
- 10 Dec 2019
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04457479
- Acronym / sponsor ID
- HYBRID
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with acute large vessel occlusion (stroke) treated with the APERIO® Hybrid(17/21) Thrombectomy Device.
Key inclusion criteria (1 listed)
- All patients treated with APERIO® HYBRID and/or APERIO® Hybrid(17/21) Thrombectomy Device as a result of an acute stroke.
Key exclusion criteria (2 listed)
- Patient age < 18 years
- Pre stroke mRS ≥ 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical success
Time frame: until 24 hours after intervention
mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)
Good clinical outcome at 90 days
Time frame: 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):
Time frame: until 24 hours after intervention
ICH in postinterventional (<24 hours) CT associated with worsening of NIHSS by ≥ 4 points within 24 hours
2 secondary outcomes
Cerebrovascular events until hospital discharge:
Time frame: between 24 hours after intervention and discharge from hospital
Cerebrovascular events at 90 days
Time frame: at 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Acandis GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: until 24 hours after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.