Acute Ischemic StrokeACUTENCT03955835
Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)
A study testing Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter. in people with Acute Ischemic Stroke and Intracranial Stenosis, run by Acandis GmbH at 8 sites in Germany.
Trial summary
Study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable Credo® stent together with the NeuroSpeed® PTA balloon catheter. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke, Intracranial Stenosis
- What is being tested?
- Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 8 sitesGermany
- Study dates
- 9 Aug 2019to 22 Sep 2021
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke from large vessel occlusion (LVO)
- Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion of intracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middle cerebral artery (MCA) (TICI 0-1)
- Small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion < 70 ml)
- Suspected underlying stenosis of the occluded artery amenable to stenting by judgement of the treating neurointerventionalist
- Age 18- 80 years
- Informed consent (see below)
- Decision to perform angioplasty and stenting < 12 hours of symptom onset
- Previous passage of occlusion with microcatheter obtained
Who cannot join
- Large infarct core prior to initiation of thrombectomy (CT ASPECTS 0-5, DWI lesion > 70 ml)
- Vessel occlusion or stenosis of different known or suspected cause than atherosclerosis (e.g. vasculitis)
- Pre-stroke disability (MRS > 2)
- Any sign of intracranial haemorrhage on brain imaging prior to thrombectomy
- Any sign of intracranial vessel perforation during thrombectomy
- Contraindication against treatment with double anti-platelet treatment
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- Current effective use of oral anticoagulants (e.g. INR > 1.7 for Vitamin K antagonists)
- More than 3 attempts for recanalization of target lesion prior to the use of the study device.
- Stenosis longer than the working length of the NeuroSpeed PTA balloon catheter.
- Diameter of the healthy vessel proximal and distal to the stenosis prevents save treatment with the NeuroSpeed PTA balloon catheter or is outside the indicated range of the Credo stent.
- Diameter of the target area is outside the indicated range of the Credo stent after predilation.
- Contraindication against anti-platelet or anticoagulation therapy
- Heavily calcified lesions that may prevent access or safe stent placement.
- Pregnant and breastfeeding women
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie
Hamburg, 22763
Universitätsklinikum Heidelberg
Heidelberg
Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes
Homburg, 66424
Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Mönchengladbach, 41063
Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
Oldenburg, 26122
Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik
Osnabrück, 49028
Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik
Solingen, 42697
About this study
Study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable Credo® stent together with the NeuroSpeed® PTA balloon catheter.
Read the detailed description
Prospective, interventional treatment, single-arm, open-label, multi-center trial.
- Conditions
- Acute Ischemic Stroke, Intracranial Stenosis
- Being tested
- Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.Device
Self-expandable Credo® stent together with NeuroSpeed® PTA balloon catheter. Credo® and NeuroSpeed® are already CE approved products, for which within ACUTE an additional new indication shall be examined.
| Study group | Role | What they receive |
|---|---|---|
| ACUTE | Other | Patients with acute ischemic stroke and proven large vessel occlusion (e.g. intracranial internal carotid artery or middle cerebral artery) with unsuccessful recanalization after endovascular treatment with mechanical thrombectomy and suspected underlying stenosis of the occluded intracranial artery amenable to stenting based on judgment by the treating neurointerventionalist. Receives: Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-Primary Technical Efficacy Endpoint
Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting).
Measured: Assessed after interventional procedure
Co-Primary Clinical Efficacy Endpoint
Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2).
Measured: 90 +/- 10 days after stroke
Primary Safety Endpoints
- Symptomatic intracranial hemorrhage (SICH) as defined in SITS-MOST (within 18-36 hours of treatment)
- Device-related procedural complications: Dissection, perforation or rupture of the target vessel, embolism, stent thrombosis or occlusion, stent migration.
Measured: Within 18-36 hours after treatment
Secondary outcomes (2)
Secondary Efficacy Endpoints
- Categorical shift in MRS 90 (±10) days after stroke
- Functional health status and quality of life 90 (±10) days after stroke (EQ-5D)
- Infarct growth by 18-36 hours after stroke as compared to predicted infarct growth
- Frequency of residual stenosis > 50 %
Measured: 90 +/- 10 days after stroke
Secondary Safety Endpoints
- Ischemic stroke in downstream territory of the occluded vessel within 90 (±10) days after stroke
- Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours
- Embolization in new territories
- Mortality 90 (±10) days after stroke
- Death or dependency 90 (±10) days after stroke (MRS 4-6)
Measured: 90 +/- 10 days after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start9 Aug 2019
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Why it stopped: CREDO stent is now CE-marked for rescue stenting (new indication).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional treatment, single-arm, open-label, multi-centre trial
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955835
- Sponsor's protocol ID
- ACUTE
- Acronym
- ACUTE
- Status last verified
- Oct 2021
- First submitted
- 16 May 2019
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)
- ClinicalTrials.gov ID
- NCT03955835
- Acronym / sponsor ID
- ACUTE / ACUTE
- Conditions
- Acute Ischemic Stroke, Intracranial Stenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CREDO stent is now CE-marked for rescue stenting (new indication).
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 20 May 2019 (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.
Study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable Credo® stent together with the NeuroSpeed® PTA balloon catheter.
Detailed description
Prospective, interventional treatment, single-arm, open-label, multi-center trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional treatment, single-arm, open-label, multi-centre trial
| Arm | Type | Receives |
|---|---|---|
| ACUTE | Other | Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.Patients with acute ischemic stroke and proven large vessel occlusion (e.g. intracranial internal carotid artery or middle cerebral artery) with unsuccessful recanalization after endovascular treatment with mechanical thrombectomy and suspected underlying stenosis of the occluded intracranial artery amenable to stenting based on judgment by the treating neurointerventionalist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Acute ischemic stroke from large vessel occlusion (LVO)
- Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion of intracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middle cerebral artery (MCA) (TICI 0-1)
- Small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion < 70 ml)
- Suspected underlying stenosis of the occluded artery amenable to stenting by judgement of the treating neurointerventionalist
- Age 18- 80 years
Key exclusion criteria (14 listed)
- Large infarct core prior to initiation of thrombectomy (CT ASPECTS 0-5, DWI lesion > 70 ml)
- Vessel occlusion or stenosis of different known or suspected cause than atherosclerosis (e.g. vasculitis)
- Pre-stroke disability (MRS > 2)
- Any sign of intracranial haemorrhage on brain imaging prior to thrombectomy
- Any sign of intracranial vessel perforation during thrombectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.Self-expandable Credo® stent together with NeuroSpeed® PTA balloon catheter. Credo® and NeuroSpeed® are already CE approved products, for which within ACUTE an additional new indication shall be examined. | Device | ACUTE |
Primary outcome
Co-Primary Technical Efficacy Endpoint
Time frame: Assessed after interventional procedure
Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting).
Co-Primary Clinical Efficacy Endpoint
Time frame: 90 +/- 10 days after stroke
Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2).
Primary Safety Endpoints
Time frame: Within 18-36 hours after treatment
* Symptomatic intracranial hemorrhage (SICH) as defined in SITS-MOST (within 18-36 hours of treatment) * Device-related procedural complications: Dissection, perforation or rupture of the target vessel, embolism, stent thrombosis or occlusion, stent migration.
2 secondary outcomes
Secondary Efficacy Endpoints
Time frame: 90 +/- 10 days after stroke
Secondary Safety Endpoints
Time frame: 90 +/- 10 days after stroke
Results and safety
The study was stopped early (reason given: CREDO stent is now CE-marked for rescue stenting (new indication).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter. in people with Acute Ischemic Stroke and Intracranial Stenosis, run by Acandis GmbH at 8 sites 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 8 inclusion and 14 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: stopped early, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 was stopped early (reason given: CREDO stent is now CE-marked for rescue stenting (new indication).). Results are not available in the source record.
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?
Co-Primary Technical Efficacy Endpoint (time frame: Assessed after interventional procedure). 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 21 Oct 2021.