Clinical trial NCT04531904: Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter
Official title: Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter for Neurothrombectomy: A Post-Market Clinical Follow-up Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
perfect
embovac
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Ischemic Stroke patients with confirmed intracranial large vessel occlusion.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Successful Revascularization
timeFrame: Day 0 (post-procedure)
Secondary outcomes:
measure: Percentage of Participants With Successful Revascularization Without Rescue Therapy
timeFrame: Day 0
measure: Percentage of Participants With Complete Revascularization
timeFrame: Day 0
measure: Percentage of Participants With First Pass Effect Without Rescue Therapy
timeFrame: Day 0
measure: Percentage of Participants With Modified First Pass Effect
timeFrame: Day 0
measure: Time to Recanalization
timeFrame: Day 0
measure: Percentage of Participants With Modified Rankin Scale (mRS) Scores 0 to 2 at Day 90
timeFrame: at Day 90
measure: Percentage of Participants With Device Related Serious Adverse Events (SAEs)
timeFrame: Up to Day 90 post procedure on Day 0
measure: Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH)
timeFrame: 24 hours post procedure on Day 0
measure: Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Total Score at 24 Hours Post-procedure
timeFrame: Baseline (Day 0, before procedure) up to 24 hours post procedure on Day 0
measure: Number of Participants With All-Cause Mortality Thorugh 90 Days
timeFrame: 90 days post procedure on Day 0
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Kyriakos Lobotesis
role: PRINCIPAL_INVESTIGATOR
References: