Intracranial StenosisASSISTENTNCT03902444
AcandiS Stenting of Intracranial STENosis - regisTry
An observational study of Intracranial Stenosis, run by Acandis GmbH at 16 sites in Germany.
Trial summary
ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Stenosis
- What is being tested?
- Credo® Stent, NeuroSpeed® PTA balloon catheter
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 16 sitesGermany
- Study dates
- May 2016to Oct 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over 18 with symptomatic intracranial artery stenosis treated with the self-expandable Credo® stent in the participating sites in clinical practice.
Who may be able to join
- Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU)
Who cannot join
- There are no specific exclusion criteria (see product IFU)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Germany16 sites, 16 recruiting
- Recruiting
Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum, 44892
Priv. Doz. Dr. med. Sebastian Fischer
- Recruiting
Uniklinik Köln
Cologne, 50924
Christoph Kabbasch, MD
- Recruiting
Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie
Düsseldorf
Bernd Turowski, Prof.
- Recruiting
Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie
Essen, 45131
Rene Chapot, Prof.
Rene Chapot, Prof
- Recruiting
Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen
Göttingen, 37075
Christian Riedel, Prof.
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Götz Thomalla, MD
Jan Buhk
- Recruiting
Asklepios Klinik Altona, Fachbereich Neuroradiologie
Hamburg, 22769
Bernd Eckert, Prof
- Recruiting
Universitätsklinikum Heidelberg Abteilung für Neuroradiologie
Heidelberg, 69120
Markus Möhlenbruch, MD
- Recruiting
Universitätsklinikum Homburg
Homburg, 66424
Wolfgang Reith, Prof.
- Recruiting
Klinikum Ingolstadt
Ingolstadt, 85049
Dr. Hendrik Janssen
- Recruiting
Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie
Magdeburg, 39120
Daniel Behme, PD Dr.
- Recruiting
Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Mönchengladbach, 41063
Prof. Ringelstein
- Recruiting
Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg
Oldenburg, 26122
Christian Mathys, MD
- Recruiting
Klinikum Osnabrück, Klinik für Neurologie
Osnabrück, 49076
Lars Krause, MD
Stephan Lowens, MD
- Recruiting
KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie
Recklinghausen, 45657
Christian Loehr, Dr.
- Recruiting
St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen
Solingen, 42697
Hannes Nordmeyer, MD
About this study
ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry.
Read the detailed description
ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge.
The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.
- Conditions
- Intracranial Stenosis
- Being tested
- Credo® Stent, NeuroSpeed® PTA balloon catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Credo® Stent, NeuroSpeed® PTA balloon catheterDevice
a self-expanding stent is used together with a PTA balloon catheter
| Study group | Role | What they receive |
|---|---|---|
| Credo® Stent and NeuroSpeed® PTA balloon catheter | Patients treated with Credo® Stent and NeuroSpeed® PTA balloon catheter in the clinical routine Receives: Device: Credo® Stent, NeuroSpeed® PTA balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Technical Success
- Technical Success
Measured: During interventional procedure
Number of Patients with Periprocedural Vascular Events
- 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: Periprocedural, until 30 days after the interventional procedure
Number of Patients with Cerebrovascular events
- 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: At hospital discharge - befor the patient leaves the hospital after the intervention; up to 2 weeks, whichever came first
Number of Patients with Cerebrovascular Events
- Intracranial haemorrhage (symptomatic / asymptomatic)
- Death
- TIA
- Non-disabling ischemic stroke (MRS 0-2)
- Disabling ischemic stroke (MRS 3-6)
- Interventional re-treatment of the target vessel
Measured: 30 days after the interventional procedure
Secondary outcomes (4)
Number of Patients with Dissection of the target vessel
Measured: During interventional procedure
Number of Patients with Occlusion of the target vessel
Measured: 30 days after the interventional procedure
Number of Patients with Myocardial infarction
Measured: 30 days after the interventional procedure
Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion)
Measured: 30 days after the interventional procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study startMay 2016
- Primary completionMar 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial StenosisStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acandis GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Götz Thomalla, MD, Principal investigator, Unversity Medical Center Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902444
- Sponsor's protocol ID
- ASSISTENT
- Acronym
- ASSISTENT
- Status last verified
- Jan 2023
- First submitted
- 27 Mar 2019
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AcandiS Stenting of Intracranial STENosis - regisTry
- ClinicalTrials.gov ID
- NCT03902444
- Acronym / sponsor ID
- ASSISTENT / ASSISTENT
- Conditions
- Intracranial Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Acandis GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 Apr 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.
ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry.
Detailed description
ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge.
The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Credo® Stent and NeuroSpeed® PTA balloon catheter | – | Device: Credo® Stent, NeuroSpeed® PTA balloon catheterPatients treated with Credo® Stent and NeuroSpeed® PTA balloon catheter in the clinical routine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over 18 with symptomatic intracranial artery stenosis treated with the self-expandable Credo® stent in the participating sites in clinical practice.
Key inclusion criteria (1 listed)
- Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU)
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria (see product IFU)
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 |
|---|---|---|
| Credo® Stent, NeuroSpeed® PTA balloon cathetera self-expanding stent is used together with a PTA balloon catheter | Device | Credo® Stent and NeuroSpeed® PTA balloon catheter |
Primary outcome
Rate of Technical Success
Time frame: During interventional procedure
• Technical Success
Number of Patients with Periprocedural Vascular Events
Time frame: Periprocedural, until 30 days after the interventional procedure
* 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
Number of Patients with Cerebrovascular events
Time frame: At hospital discharge - befor the patient leaves the hospital after the intervention; up to 2 weeks, whichever came first
* 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
Number of Patients with Cerebrovascular Events
Time frame: 30 days after the interventional procedure
* Intracranial haemorrhage (symptomatic / asymptomatic) * Death * TIA * Non-disabling ischemic stroke (MRS 0-2) * Disabling ischemic stroke (MRS 3-6) * Interventional re-treatment of the target vessel
4 secondary outcomes
Number of Patients with Dissection of the target vessel
Time frame: During interventional procedure
Number of Patients with Occlusion of the target vessel
Time frame: 30 days after the interventional procedure
Number of Patients with Myocardial infarction
Time frame: 30 days after the interventional procedure
Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion)
Time frame: 30 days after the interventional procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- 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.
Götz Thomalla, MD principal investigator
Unversity Medical Center Hamburg-Eppendorf
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Stenosis, run by Acandis GmbH at 16 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Acandis GmbH (+49 723 1155 00, info@acandis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Technical Success (time frame: During interventional procedure). The study lists 4 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 1 Feb 2023.