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ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox GmbH* Germany) will be examined. The effectiveness, safety and the long-term success when using the pREset to treat acute occlusions of cerebral vessels will be analyzed.
*German: "Gesellschaft mit beschränkter Haftung", limited liability company
ARTESp is a prospective multicenter study in which the pREset thrombectomy system (phenox GmbH Germany) will be examined. The effectiveness, safety and the long-term success when using the pREset to treat acute occlusions of cerebral vessels will be analyzed.
In this study the market-approved, self-expandable stent retriever (pREset, phenox GmbH, Germany) will be used to achieve a direct flow recovery.
The thrombectomy system will be unfolded directly in the vessel occlusion. In a second step, the system and the thrombus will be pulled back into the guide catheter.
It is planned to enroll 100 patients at the age of 18 until 85 years, with a NIHSS (National Institutes of Health Stroke Scale) ≥ 8 and ≤ 30. The preconditions for study enrollment are the written consent of the patient or of the legal representative and the fulfillment of all mentioned inclusion and exclusion criteria. Pregnant women are excluded from study participation.The clinical interventions are in accordance with the clinical standard of care for the treatment of this patient population.
The mRS (Modified Rankin Scale) on day 30, the NIHSS on day 90 and an imaging procedure on day 90 may be performed by the study site provided that it corresponds to the clinical standards of the study site.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pREset thrombectomy retriever | Device | Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA). |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological Condition of the Patient | modified Rankin Scale (mRS) Neurological Condition is measured by the "Modified Rankin Scale (mRS)". This scale ranges from 0 - 6: 0 = No symptoms at all;
| 90 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological Condition of the Patient | The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are:
CLASSIFICATION: 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH\_Stroke\_Scale.pdf |
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Inclusion Criteria:
Exclusion Criteria:
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100 patients harboring an acute ischemic stroke in at least one of the major intracranial arteries
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Reith, Prof. | Universitätsklinikum des Saarlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Katharinenhospital | Stuttgart | Baden-Wurttemberg | 70174 | Germany | ||
| Klinikum rechts der Isar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27530601 | Derived | Prothmann S, Schwaiger BJ, Gersing AS, Reith W, Niederstadt T, Felber A, Kurre W. Acute Recanalization of Thrombo-Embolic Ischemic Stroke with pREset (ARTESp): the impact of occlusion time on clinical outcome of directly admitted and transferred patients. J Neurointerv Surg. 2017 Sep;9(9):817-822. doi: 10.1136/neurintsurg-2016-012556. Epub 2016 Aug 16. |
| Label | URL |
|---|---|
| phenox GmbH | View source |
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No assignment to groups was performed due to single-arm study.
115 patients started the study, but little by little, 15 patients were excluded/discontinued due to screening failure or withdrawn consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | Treated with pREset Thrombectomy Retriever |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Treated with pREset Thrombectomy Retriever |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neurological Condition of the Patient | modified Rankin Scale (mRS) Neurological Condition is measured by the "Modified Rankin Scale (mRS)". This scale ranges from 0 - 6: 0 = No symptoms at all;
| All Patients | Posted | Number | patients | 90 days after treatment |
|
90 days after procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | Treated with pREset Thrombectomy Retriever |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mortality | Injury, poisoning and procedural complications | Non-systematic Assessment | Led to death |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extravasation | Vascular disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Affairs | phenox GmbH | +49 (0)234 36 919 | 0 | ARTESp@phenox.info |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 24 to 72 hr after treatment |
| Intracranial Hemorrhage (ICH) | Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites. | 24 hr after treatment |
| Time From Groin Puncture to Recanalization | during intervention, up to 3 hr |
| Recanalization of the Target Vessel | original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion. | at the end of intervention, up to 3 hr |
| No. of Passages Needed to Reach the Final TICI Score With pREset | during intervention, up to 3 hr |
| München |
| Bavaria |
| 81675 |
| Germany |
| Universitätsklinikum Münster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | Saarland | 66424 | Germany |
| years |
|
| Sex: Female, Male | Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Neurological Condition of the Patient | The National Institutes of Health Stroke Scale (NIHSS) is a commonly used measure to assess the severity of a stroke. All items are rated and scores are added at the end. A higher score corresponds to a more severe stroke. Assessed are:
CLASSIFICATION: 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke As published by ninds.nih.gov: http://www.ninds.nih.gov/doctors/NIH\_Stroke\_Scale.pdf | All Patients | Posted | Median | Full Range | NIHSS score | 24 to 72 hr after treatment |
|
|
|
| Secondary | Intracranial Hemorrhage (ICH) | Intracranial hemorrhage was assessed via imaging material (e.g. Digital Subtraction Angiography - DSA or CT) as forwarded by the clinical sites. | All Patients | Posted | Number | patients | 24 hr after treatment |
|
|
|
| Secondary | Time From Groin Puncture to Recanalization | All Patients | Posted | Median | Full Range | minutes | during intervention, up to 3 hr |
|
|
|
| Secondary | Recanalization of the Target Vessel | original Thrombolysis in Cerebral Infarction score (o-TICI) The TICI scale indicates perfusion of an occluded blood vessel, it is used in angiographic imaging. Grade 0 = no perfusion Grade 1 = Penetration with minimal perfusion. The contrast material passes beyond the area of obstruction but fails to opacify the entire cerebral bed distal to the obstruction for the duration of the angiographic run, Grade 2a = Only partial filling (<2/3) of the entire vascular territory is visualized, Grade 2b = Complete filling of all of the expected vascular territory is visualized, but the filling is slower than normal, Grade 3 = complete perfusion. | 100 patients harboured 109 vessel occlusions | Posted | Number | number of vessels | at the end of intervention, up to 3 hr | vessel occlusions | vessel occlusions |
|
|
|
| Secondary | No. of Passages Needed to Reach the Final TICI Score With pREset | 100 patients harboured 109 vessel occlusions | Posted | Mean | Standard Deviation | passes | during intervention, up to 3 hr | vessel occlusions | vessel occlusions |
|
|
|
| 7 |
| 100 |
| 24 |
| 100 |
|
| Vasospasm | Vascular disorders | Non-systematic Assessment |
|
| Emboli to a new territory | Vascular disorders | Non-systematic Assessment |
|
| Emboli to the same territory | Vascular disorders | Non-systematic Assessment |
|
| Focal subarachnoid hemorrhages around the target vessel | Vascular disorders | Non-systematic Assessment |
|
| PH I | Vascular disorders | Non-systematic Assessment |
|
| PH II | Vascular disorders | Non-systematic Assessment |
|
Data must only be published after completion of the study. Publication of e.g. single center experience within the study is not allowed until the aggregate data have been submitted.
All information and data generated in association with this study will be held in strict confidence and remain in the sole property of phenox GmbH. The investigator agrees to use this information for the sole purpose of completing this study and for no other purpose without written consent from phenox GmbH.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|
|
| TICI 2b |
|
| TICI 3 |
|