Acute StrokeENDOSTROKENCT01399762
International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke
An observational study of Acute Stroke, run by Goethe University at 13 sites in 2 countries.
Trial summary
The purpose of the Endostroke Registry is to gather information on predictors of good or poor clinical outcome following mechanical recanalization therapies for acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- mechanical recanalization
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jan 2011to not given
- 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 with acute ischemic stroke being treated with mechanical recanalization devices for proximal vessel occlusion of brain supplying arteries (i.e. MCA main stem occlusion, basilar artery occlusion, distal ICA occlusion)
Who may be able to join
- Patients being treated with mechanical recanalization devices due to an acute proximal arterial vessel occlusion of brain supplying arteries
Who cannot join
- Patients being treated with mechanical recanalization devices for venous vessel occlusion.
- Patients being treated with mechanical recanalization devices due to an acute vessel occlusion which occured as a complication of an angiographic procedure scheduled for other reasons (i.e. as a complication of a diagnostic angiography or coiling procedure for cerebral aneurysms)
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Germany11 sites, 5 recruiting
- Active, not recruiting
Departments of Neurology and Neuroradiology, University Hospital
Aachen, 52074
- Not yet recruiting
Departments of Neurology and Radiology, Klinikum Altenburger Land
Altenburg, 04600
- Recruiting
Departments of Neurology and Neuroradiology, Charite University Hospital
Berlin, 10117
- Active, not recruiting
Departments of Neurology and Neuroradiology, University Hospital
Düsseldorf, 40255
- Recruiting
Departments of Neurology and Neuroradiology, University Hospital
Essen, 45122
- Recruiting
Hirngefaesszentrum Goethe University
Frankfurt, 60528
- Recruiting
Departments of Neurology and Neuroradiology, Klinikum Fulda
Fulda, 36043
- Active, not recruiting
Departments of Neurology and Neuroradiology, University Hospital
Giessen, 35385
- Active, not recruiting
Departments of Neurology and Neuroradiology, University Hospital
Kiel, 24105
- Active, not recruiting
Departments of Neurology and Neuroradiology, University Hospital
Mainz, 55131
- Active, not recruiting
Departments of Neurology and Neuroradiology, Knappschaftskrankenhaus
Recklinghausen, 45657
Austria2 sites, 2 recruiting
- Recruiting
Departments of Neurology and Neuroradiology, University Hospital
Graz, 8036
- Recruiting
Departments of Neurology and Neuroradiology, Landes-Nervenklinik Wagner-Jauregg
Linz, 4020
About this study
Official title: International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE)
The purpose of the Endostroke Registry is to gather information on predictors of good or poor clinical outcome following mechanical recanalization therapies for acute ischemic stroke.
Read the detailed description
Mechanical recanalization procedures are increasingly used in large vessel stroke, i.e. in proximal middle cerebral artery (MCA) or basilar artery (BA) occlusion. This trend is due to the limited efficacy of the only approved acute stroke treatment, systemic thrombolysis, in large vessel occlusion but also due to new technical innovations triggering the development of numerous devices for thrombus extraction. Within large single-arm trials, some of these devices demonstrated their potential with respect to acceptable complication- and substantial recanalization rates. Nevertheless, clinical outcome of these stroke patients is frequently poor despite an elaborate, aggressive, but also complex and costly treatment regimen. The factors determining good or poor clinical outcome in mechanical recanalization remain to be determined. The goal of the ENDOSTROKE-registry is the systemic evaluation of technical and clinical features that might be important for the further development and evaluation of endovascular treatment strategies for acute stroke. Special emphasis is laid on the assessment of clinical outcome (90 day MRS). Concerning technical and periprocedural aspects, a focus is put on time issues i.e. intra-hospital time delays, duration of angiographic procedures until vessel patency is achieved.It is planned to enroll approximately 500 patients in this registry. In first line, prospective patients will be included in the register (start date January 2011) but retrospective inclusion of patients being treated within the three years before the start of the register is allowed as long a consecutive patient registration is guaranteed (to exclude selection bias). Data analysis will include univariate and multivariate approaches with respect to clinical outcome measures.
- Conditions
- Acute Stroke
- Being tested
- mechanical recanalization
- Keywords
- stroke, acute, mechanical recanalization, interventional neuroradiology, clinical registry
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical recanalizationDevice
Endovascular thrombus extraction by mechanical recanalization devices
| Study group | Role | What they receive |
|---|---|---|
| mechanical recanalization | Patients with acute stroke being treated with endovascular devices for mechanical recanalization (no restriction to specific endovascular devices) Receives: Device: mechanical recanalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
Proportion of patients with favourable clinical outcome defined as a Modified Rankin Score (MRS) of 0,1, or 2 three months after the intervention.
Measured: approx. 90 days after stroke onset
Secondary outcomes (2)
Angiographic outcome
Proportion of patients with complete recanalization defined as Thrombolysis in Myocardial Infarction (TIMI) Grade 2 or 3.
Measured: Day of intervention
Complication rate
Periprocedural complication rate defined as a combination of symptomatic intracranial hemorrhage (ECASS classification PH I and PH II), subarachnoid hemorrhage and thrombembolic events.
Measured: within 36 h after endovascular procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJan 2011
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
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Investigators
- Oliver C. Singer, MD, Principal investigator, Hirngefaesszentrum Goethe University Frankfurt GermanyJoachim Berkefeld, MD, Principal investigator, Hirngefaesszentrum Goethe University Frankfurt Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399762
- Sponsor's protocol ID
- Endostroke_01
- Acronym
- ENDOSTROKE
- Status last verified
- Jul 2011
- First submitted
- 18 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicenter Registry for Mechanical Recanalization Procedures in Acute Stroke (ENDOSTROKE)
- ClinicalTrials.gov ID
- NCT01399762
- Acronym / sponsor ID
- ENDOSTROKE / Endostroke_01
- Conditions
- Acute Stroke
- Keywords
- stroke, acute, mechanical recanalization, interventional neuroradiology, clinical registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 22 Jul 2011 (estimated)
- 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.
The purpose of the Endostroke Registry is to gather information on predictors of good or poor clinical outcome following mechanical recanalization therapies for acute ischemic stroke.
Detailed description
Mechanical recanalization procedures are increasingly used in large vessel stroke, i.e. in proximal middle cerebral artery (MCA) or basilar artery (BA) occlusion. This trend is due to the limited efficacy of the only approved acute stroke treatment, systemic thrombolysis, in large vessel occlusion but also due to new technical innovations triggering the development of numerous devices for thrombus extraction. Within large single-arm trials, some of these devices demonstrated their potential with respect to acceptable complication- and substantial recanalization rates. Nevertheless, clinical outcome of these stroke patients is frequently poor despite an elaborate, aggressive, but also complex and costly treatment regimen. The factors determining good or poor clinical outcome in mechanical recanalization remain to be determined. The goal of the ENDOSTROKE-registry is the systemic evaluation of technical and clinical features that might be important for the further development and evaluation of endovascular treatment strategies for acute stroke. Special emphasis is laid on the assessment of clinical outcome (90 day MRS). Concerning technical and periprocedural aspects, a focus is put on time issues i.e. intra-hospital time delays, duration of angiographic procedures until vessel patency is achieved.It is planned to enroll approximately 500 patients in this registry. In first line, prospective patients will be included in the register (start date January 2011) but retrospective inclusion of patients being treated within the three years before the start of the register is allowed as long a consecutive patient registration is guaranteed (to exclude selection bias). Data analysis will include univariate and multivariate approaches with respect to clinical outcome measures.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mechanical recanalization | – | Device: mechanical recanalizationPatients with acute stroke being treated with endovascular devices for mechanical recanalization (no restriction to specific endovascular devices) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke being treated with mechanical recanalization devices for proximal vessel occlusion of brain supplying arteries (i.e. MCA main stem occlusion, basilar artery occlusion, distal ICA occlusion)
Key inclusion criteria (1 listed)
- Patients being treated with mechanical recanalization devices due to an acute proximal arterial vessel occlusion of brain supplying arteries
Key exclusion criteria (2 listed)
- Patients being treated with mechanical recanalization devices for venous vessel occlusion.
- Patients being treated with mechanical recanalization devices due to an acute vessel occlusion which occured as a complication of an angiographic procedure scheduled for other reasons (i.e. as a complication of a diagnostic angiography or coiling procedure for cerebral aneurysms)
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 |
|---|---|---|
| mechanical recanalizationEndovascular thrombus extraction by mechanical recanalization devices | Device | mechanical recanalization |
Primary outcome
Clinical outcome
Time frame: approx. 90 days after stroke onset
Proportion of patients with favourable clinical outcome defined as a Modified Rankin Score (MRS) of 0,1, or 2 three months after the intervention.
2 secondary outcomes
Angiographic outcome
Time frame: Day of intervention
Complication rate
Time frame: within 36 h after endovascular procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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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.
Oliver C. Singer, MD principal investigator
Hirngefaesszentrum Goethe University Frankfurt Germany
Joachim Berkefeld, MD principal investigator
Hirngefaesszentrum Goethe University Frankfurt Germany
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Goethe University at 13 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Austria. 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 Oliver C Singer, MD (+49 69 6301 5942, o.singer@em.uni-frankfurt.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: approx. 90 days after stroke onset). 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 22 Jul 2011.