- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678169
European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke (PROMISE)
A Prospective, Multicenter, Observational, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.
The follow-up visit will occur 24 hours, 7-10 days or discharge, 30 days and 90 days post-procedure and will review patient's functional outcome, quality of life, and adverse events.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Lübeck, Germany, 23538
- Universitätsklinikum Schleswig-Holstein
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
General inclusion criteria:
- From 18 years of age
- Present with symptoms consistent with an acute ischemic stroke within 6 hours of stroke symptom onset
- Arterial occlusion of the distal intracranial carotid artery (ICA and ICA terminus) or middle cerebral artery (M1/M2)
- National Institute of Health Stroke Scale (NIHSS) ≥ 2
- Signed Informed Consent Form.
Imaging inclusion criteria:
• CT ASPECT score from 6 to 10 (>6) or according to MR DWI ASPECT score from 5 to 10 (>5).
Exclusion Criteria:
General exclusion criteria:
- Associated myocardial infarction or severe infection (endocarditis or sepsis)
- Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) of > 3.0 or platelets count < 40 x109/L or APTT > 50 sec
- Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg)
- Baseline glucose < 2.7 or > 22.2 mmol/L
- Pre-stroke mRS score > 2
- Seizure at the onset of stroke
- Arterial tortuosity that would prevent the device from reaching the target vessel
- Time of stroke symptoms onset unknown
- Life expectancy less than 90 days prior to stroke onset
- Females who are pregnant or lactating
- Known serious sensitivity to radiographic contrast media.
Imaging exclusion criteria:
CT/MRI evidence of the following conditions at screening:
- Significant mass effect with midline shift
- Evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM)
- Angiographic evidence of tandem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion criterion.
- Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Penumbra Aspiration System
Penumbra Aspiration System with the ADAPT technique
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Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score.
Time Frame: Immediate post-procedure
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Immediate post-procedure
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Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2.
Time Frame: 90 days post-procedure
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90 days post-procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of device and procedure related Serious Adverse Events (SAEs) at 24 hours and 30 days from stroke treatment
Time Frame: 24 hours and 30 days from stroke treatment
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24 hours and 30 days from stroke treatment
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All causes of mortality and morbidity at 90 days
Time Frame: 90 days
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90 days
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Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
Time Frame: At the end of interventional surgical procedure
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At the end of interventional surgical procedure
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Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours
Time Frame: 24 hours
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24 hours
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Occurrence of vessel damages at the end of the ADAPT procedure.
Time Frame: At the end of the interventional surgical procedure
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At the end of the interventional surgical procedure
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NIHSS score at 7-10 days post-procedure.
Time Frame: 7-10 days post-procedure
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7-10 days post-procedure
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Times to revascularization
Time Frame: From symptom onset to various times during the interventional surgical procedure
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From symptom onset to various times during the interventional surgical procedure
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Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure.
Time Frame: 90 days
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90 days
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Heath Economics: Total duration of hospitalization with related healthcare resources
Time Frame: Average time frame 3-7 days.
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Average time frame 3-7 days.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Schramm, MD, Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
Publications and helpful links
General Publications
- Blanc R, Redjem H, Ciccio G, Smajda S, Desilles JP, Orng E, Taylor G, Drumez E, Fahed R, Labreuche J, Mazighi M, Lapergue B, Piotin M. Predictors of the Aspiration Component Success of a Direct Aspiration First Pass Technique (ADAPT) for the Endovascular Treatment of Stroke Reperfusion Strategy in Anterior Circulation Acute Stroke. Stroke. 2017 Jun;48(6):1588-1593. doi: 10.1161/STROKEAHA.116.016149. Epub 2017 Apr 20. Erratum In: Stroke. 2017 Jun;48(6):e152.
- Schramm P, Navia P, Papa R, Zamarro J, Tomasello A, Weber W, Fiehler J, Michel P, Pereira VM, Krings T, Gralla J, Santalucia P, Pierot L, Lo TH. ADAPT technique with ACE68 and ACE64 reperfusion catheters in ischemic stroke treatment: results from the PROMISE study. J Neurointerv Surg. 2019 Mar;11(3):226-231. doi: 10.1136/neurintsurg-2018-014122. Epub 2018 Jul 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLP 9508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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