Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter

Acute Ischemic Stroke Clinical Trial

— PERFECT  

Official title:

Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter for Neurothrombectomy: A Post-Market Clinical Follow-up Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531904
• Other study ID #: CNV_2019_01
• Status: Completed
• Start date: October 15, 2020
• Est. completion date: July 26, 2022

Study information

• Verified date: May 2023
• Source: Cerenovus, Part of DePuy Synthes Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A post-market study evaluating the EMBOVAC Aspiration Catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 26, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject = 18 years old.

2. 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

3. A clinical decision has been made to use the EMBOVAC™ aspiration catheter prior to enrollment in the research

4. EMBOVAC™ Aspiration Catheter is attempted to be used for the first 3 clot removal passes for the target intracranial occlusion

5. Pre-stroke mRS = 1

6. NIHSS = 30

7. Informed Consent has been provided by the subject or the subject's legally authorized representative.

Exclusion Criteria

1. Potential study candidate has already undergone standard of care assessments or treatment that deviate from the clinical research protocol requirements

2. 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

3. Known cerebral vasculitis.

4. Known cancer with life expectancy less than 12 months.

5. Stenosis, or any occlusion, in a vessel proximal to the target occlusion that requires treatment or prevents access to the site of occlusion.

6. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.

7. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma).

8. Evidence of dissection in the extra or intracranial cerebral arteries.

9. Occlusions in multiple vessels.

10. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication).

11. Currently participating in an investigational clinical trial that may confound study endpoints.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

Device:
• EMBOVAC Aspiration Catheter
The EMBOVAC Aspiration catheter is used to treat acute ischemic stroke. The catheter can be used to facilitate introduction of diagnostic or therapeutic agents and is also intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the neuro vasculature.

Locations

Country	Name	City	State
Germany	Asklepios Klinik Altona	Hamburg
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Cerenovus, Part of DePuy Synthes Products, Inc.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Successful Revascularization	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.	Day 0 (post-procedure)
Secondary	Percentage of Participants With Successful Revascularization Without Rescue Therapy	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.	Day 0
Secondary	Percentage of Participants With Complete Revascularization	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.	Day 0
Secondary	Percentage of Participants With First Pass Effect Without Rescue Therapy	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.	Day 0
Secondary	Percentage of Participants With Modified First Pass Effect	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.	Day 0
Secondary	Time to Recanalization	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".	Day 0
Secondary	Percentage of Participants With Modified Rankin Scale (mRS) Scores 0 to 2 at Day 90	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.	at Day 90
Secondary	Percentage of Participants With Device Related Serious Adverse Events (SAEs)	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).	Up to Day 90 post procedure on Day 0
Secondary	Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH)	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.	24 hours post procedure on Day 0
Secondary	Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Total Score at 24 Hours Post-procedure	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).	Baseline (Day 0, before procedure) up to 24 hours post procedure on Day 0
Secondary	Number of Participants With All-Cause Mortality Thorugh 90 Days	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.	90 days post procedure on Day 0