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

Cerenovus

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: EMBOVAC Aspiration Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT04531904

CNV_2019_01

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design