European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke (PROMISE)
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ClinicalTrials.gov Identifier: NCT02678169 |
Recruitment Status :
Completed
First Posted : February 9, 2016
Last Update Posted : January 17, 2018
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Condition or disease | Intervention/treatment |
---|---|
Ischemic Stroke | Device: Penumbra Aspiration System |
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 : | Observational |
Actual Enrollment : | 204 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective, Multicenter, Observational, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke |
Actual Study Start Date : | February 2016 |
Actual Primary Completion Date : | November 2017 |
Actual Study Completion Date : | November 2017 |

Group/Cohort | Intervention/treatment |
---|---|
Penumbra Aspiration System
Penumbra Aspiration System with the ADAPT technique
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Device: Penumbra Aspiration System
Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain |
- 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 ]
- Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2. [ Time Frame: 90 days post-procedure ]
- 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 ]
- All causes of mortality and morbidity at 90 days [ Time Frame: 90 days ]
- 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 ]
- Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours [ Time Frame: 24 hours ]
- Occurrence of vessel damages at the end of the ADAPT procedure. [ Time Frame: At the end of the interventional surgical procedure ]
- NIHSS score at 7-10 days post-procedure. [ Time Frame: 7-10 days post-procedure ]
- Times to revascularization [ Time Frame: From symptom onset to various times during the interventional surgical procedure ]
- From symptom onset to CT-scan/MRI at the institution
- From CT-scan/MRI at the institution to groin access
- From groin puncture to final revascularization result.
- Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure. [ Time Frame: 90 days ]
- Heath Economics: Total duration of hospitalization with related healthcare resources [ Time Frame: Average time frame 3-7 days. ]
- Health care professionals encountered/consulted before/after intervention
- Tests performed before/after intervention.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678169
Germany | |
Universitätsklinikum Schleswig-Holstein | |
Lübeck, Germany, 23538 |
Principal Investigator: | Peter Schramm, MD | Universitätsklinikum Schleswig-Holstein, Lübeck, Germany |
Responsible Party: | Penumbra Inc. |
ClinicalTrials.gov Identifier: | NCT02678169 |
Other Study ID Numbers: |
CLP 9508 |
First Posted: | February 9, 2016 Key Record Dates |
Last Update Posted: | January 17, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |