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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
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Ischemic Stroke Device: Penumbra Aspiration System

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 Design
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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
Groups and Cohorts
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Group/Cohort Intervention/treatment
Penumbra Aspiration System
Penumbra Aspiration System with the ADAPT technique
 Device: Penumbra Aspiration System
Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2. [ Time Frame: 90 days post-procedure ]

Secondary Outcome Measures :
  1. 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 ]
  2. All causes of mortality and morbidity at 90 days [ Time Frame: 90 days ]
  3. 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 ]
  4. Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours [ Time Frame: 24 hours ]
  5. Occurrence of vessel damages at the end of the ADAPT procedure. [ Time Frame: At the end of the interventional surgical procedure ]
  6. NIHSS score at 7-10 days post-procedure. [ Time Frame: 7-10 days post-procedure ]
  7. 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.

  8. Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure. [ Time Frame: 90 days ]
  9. 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.


Eligibility Criteria
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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
Study Population
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)
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: Peter Schramm, MD Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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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