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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CERENOVUS Neurothrombectomy Devices Registry

NCT03685578

Cerebral Stroke

COMPLETED

Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial

NCT05611242

Acute Ischemic Stroke

RECRUITING PHASE3

Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)

NCT03753061

Large Vessel Occlusion Acute Ischemic Stroke Cerebrovascular Disorders

UNKNOWN NA

Mechanical Thrombectomy Of Acute Occlusion In Ischemic Stroke

NCT03144960

Acute Stroke

UNKNOWN NA

Which Factors Influence the Duration and the Success of Mechanical Thrombectomy During the Acute Phase of Cerebral Infarction?

NCT03451903

Acute Stroke

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No