- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531904
Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter (PERFECT)
May 2, 2023 updated by: Cerenovus, Part of DePuy Synthes Products, Inc.
Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter for Neurothrombectomy: A Post-Market Clinical Follow-up Trial.
A post-market study evaluating the EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The PERFECT Study is a prospective, multi-center, single arm, post-market clinical follow-up study.
The objective of this post-market clinical follow-up study is to assess the performance of the EMBOVAC Aspiration Catheter in the treatment of acute ischemic stroke in a real-world clinical setting.
The study will also report on clot characteristics and clinical outcomes.
Study Type
Observational
Enrollment (Actual)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hamburg, Germany
- Asklepios Klinik Altona
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London, United Kingdom
- Imperial College Healthcare NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Acute Ischemic Stroke patients with confirmed intracranial large vessel occlusion.
Description
Inclusion Criteria:
- Subject ≥ 18 years old.
- Subject experiencing acute ischemic stroke with angiographic confirmation of Large Vessel Occlusion of the distal intracranial internal carotid artery, middle cerebral artery or anterior cerebral artery
- A clinical decision has been made to use the EMBOVAC™ aspiration catheter prior to enrollment in the research
- EMBOVAC™ Aspiration Catheter is attempted to be used for the first 3 clot removal passes for the target intracranial occlusion
- Pre-stroke mRS ≤ 1
- NIHSS ≤ 30
- Informed Consent has been provided by the subject or the subject's legally authorized representative.
Exclusion Criteria
- Potential study candidate has already undergone standard of care assessments or treatment that deviate from the clinical research protocol requirements
- All patients with severe hypertension on presentation. All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy
- Known cerebral vasculitis.
- Known cancer with life expectancy less than 12 months.
- Stenosis, or any occlusion, in a vessel proximal to the target occlusion that requires treatment or prevents access to the site of occlusion.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).
- Evidence of dissection in the extra or intracranial cerebral arteries.
- Occlusions in multiple vessels.
- Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication).
- Currently participating in an investigational clinical trial that may confound study endpoints.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Successful Revascularization
Time Frame: Day 0 (post-procedure)
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Successful revascularization was defined as achieving a final modified thrombolysis in cerebral infarction (mTICI) score of 2b or greater in target vessel.
Revascularization was measured by an independent adjudicating imaging core laboratory and were reported using expanded treatment in cerebral infarction (eTICI) scale.
eTICI was a 7-point grading system for determining response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent(%) filling of downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in [50-66%] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory); 2c=Reperfusion in [90-99%] of downstream territory; 3=Complete and 100% reperfusion where higher score indicated more successful revascularization.
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Day 0 (post-procedure)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Successful Revascularization Without Rescue Therapy
Time Frame: Day 0
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Percentage of participants with successful revascularization without rescue therapy was reported.
In this outcome measure, successful revascularization was defined as achieving a final mTICI score of 2b or greater in the target vessel as determined by the Independent Imaging Core Laboratory without use of rescue therapy.
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Day 0
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Percentage of Participants With Complete Revascularization
Time Frame: Day 0
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Complete revascularization was defined as achieving a final mTICI score of 2c or greater in the target vessel as determined by the Independent Imaging Core Laboratory.
Revascularization was measured by an independent adjudicating imaging core laboratory and were reported using expanded treatment in cerebral infarction(eTICI) scale.
eTICI was a 6-point grading system for determining response of thrombolytic therapy for ischemic stroke:0=No reperfusion; 0 percent (%) filling of downstream territory;1=Thrombus reduction without any reperfusion of distal arteries;2a=Reperfusion in less than half (1-49%) of territory; 2b=2b50 (reperfusion in [50-66%] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory);2c=Reperfusion in [90-99%] of downstream territory;3=Complete and 100% reperfusion where higher score indicated successful revascularization.
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Day 0
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Percentage of Participants With First Pass Effect Without Rescue Therapy
Time Frame: Day 0
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Percentage of participants with first pass effect without rescue therapy (mTICI score of 2c or greater after the first pass with the EMBOVAC Aspiration Catheter as determined by the Independent Imaging Core Laboratory) was reported.
First pass effect was described as a complete revascularization obtained after a single device pass with no rescue therapy.
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Day 0
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Percentage of Participants With Modified First Pass Effect
Time Frame: Day 0
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Percentage of participants with modified first pass effect was reported.
Modified first pass effect was defined as mTICI of 2b or greater after the first pass with the EMBOVAC aspiration catheter as determined by the Independent Imaging Core Laboratory.
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Day 0
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Time to Recanalization
Time Frame: Day 0
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Time (in minutes) to recanalization (reopening of a previously occluded passageway within a blood vessel) was defined as the procedure time from arterial puncture to recanalization (achievement of the first mTICI score >=2b as determined by the core laboratory) or visualization of final angiographic result if an mTICI score of 2b or greater was not achieved".
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Day 0
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Percentage of Participants With Modified Rankin Scale (mRS) Scores 0 to 2 at Day 90
Time Frame: at Day 90
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Percentage of participants with mRS scores 0 to 2 at 90 days was reported.
The mRS is a scale commonly used to measure the degree of disability or dependence in the daily activities in participants following stroke or other neurological event.
It was a 7-point scale that ranged from 0 to 6 where 0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death.
A lower number indicated lower disability.
The mRS evaluation at 90 days was performed by an independent assessor.
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at Day 90
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Percentage of Participants With Device Related Serious Adverse Events (SAEs)
Time Frame: Up to Day 90 post procedure on Day 0
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SAE was any untoward medical occurrence that at any dose may result in death,life-threatening illness or injury, permanent impairment of body structure or body function including chronic diseases, in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, fetal distress, fetal death or congenital abnormality or birth defect including physical or mental impairment.
Serious adverse device effect was adverse device effect that was resulted in any of consequences characteristic of SAE.
Any device related serious adverse event associated with the use of EMBOVAC Aspiration Catheter (or cannot be ruled out as having caused the event) up to 90 days post index stroke procedure.
Device relatedness was adjudicated by an independent Clinical Events Committee (CEC).
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Up to Day 90 post procedure on Day 0
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Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH)
Time Frame: 24 hours post procedure on Day 0
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Percentage of participants with sICH according to Heidelberg Bleeding Classification at 24 hours (hr) post procedure was reported.
sICH:new intracranial hemorrhage detected by brain imaging (measured 24 hr post intervention) associated with any of item:>=4 points total National Institute of Health Stroke Scale (NIHSS:tool used by healthcare providers to objectively quantify impairment caused by stroke) at time of diagnosis compared to immediately before worsening; >=2 point in 1 NIHSS category.
Rationale:to capture new hemorrhages that produced new neurological symptoms, making it clearly symptomatic but not causing worsening in original stroke territory; lead to intubation/hemicraniectomy/external ventricular drain placement or other major medical/surgical intervention or absence of alternative explanation for deterioration.
Independent imaging core laboratory reviewed all 24 hr imaging to identify all ICH.
Independent Clinical Events Committee judged ICH as symptomatic/asymptomatic.
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24 hours post procedure on Day 0
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Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Total Score at 24 Hours Post-procedure
Time Frame: Baseline (Day 0, before procedure) up to 24 hours post procedure on Day 0
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Change from baseline in NIHSS total Score at 24 hours post procedure was reported.
NIHSS is an assessment which objectively quantifies the impairment caused by stroke.
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, 0=normal function in that specific ability, while a higher score (4)=some level of impairment.
The individual scores from each item are summed in order to calculate a participant's total NIHSS score.
The participant's total NIHSS score ranges from 0 (minimum) - 42 (maximum).
Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).
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Baseline (Day 0, before procedure) up to 24 hours post procedure on Day 0
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Number of Participants With All-Cause Mortality Thorugh 90 Days
Time Frame: 90 days post procedure on Day 0
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Number of participants with all-cause mortality through 90 days post procedure was reported.
All-cause mortality included all deaths of participants due to any cause.
Participants without events were censored at the date of last contact in the study.
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90 days post procedure on Day 0
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Other Outcome Measures
Outcome Measure |
Time Frame |
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Hospitalization length of stay
Time Frame: 90 Days
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90 Days
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Healthcare resource utilization
Time Frame: 90 Days
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90 Days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kyriakos Lobotesis, Imperial College Healthcare NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2020
Primary Completion (Actual)
May 2, 2022
Study Completion (Actual)
July 26, 2022
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
August 31, 2020
Study Record Updates
Last Update Posted (Estimated)
January 26, 2024
Last Update Submitted That Met QC Criteria
May 2, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNV_2019_01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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