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

NCT04531904 | Completed Results

• 1 other identifier: CNV_2019_01
• Study Type: observational
• Target: 102
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; perfect; embovac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Percentage of Participants With Successful Revascularization Without Rescue Therapy

  Day 0

• Percentage of Participants With Complete Revascularization

  Day 0

• Percentage of Participants With First Pass Effect Without Rescue Therapy

  Day 0

• Percentage of Participants With Modified First Pass Effect

  Day 0

• Time to Recanalization

  Day 0

Interventions

EMBOVAC Aspiration Catheter DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute Ischemic Stroke patients with confirmed intracranial large vessel occlusion.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cerenovus, Part of DePuy Synthes Products, Inc.: lead

Study Sites (2)

Asklepios Klinik Altona

Hamburg, Germany

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

Related Publications (1)

• Piano M, Jansen O, Marnat G, Gory B, Nordmeyer H, Eckert B, Pedicelli A, Cognard C, Loehr C, Zanoni M, Schaefer A, Macera A, Fiehler J, Doyle K, Lobotesis K. Prospective evaluation to characterize the real-world performance of the EMBOVAC aspiration catheter for neurothrombectomy: a post-market clinical follow-up trial. J Neurointerv Surg. 2025 Feb 14;17(3):254-260. doi: 10.1136/jnis-2023-021407.

  PMID: 38609174 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Clot / Thrombus

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Cerenovus Clinical Research Director
• Organization: CERENOVUS

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Kyriakos Lobotesis

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 31, 2020
• Study Start: October 15, 2020
• Primary Completion: May 2, 2022
• Study Completion: July 26, 2022
• Last Updated: January 26, 2024
• Results First Posted: January 26, 2024

Record last verified: 2023-05

Locations

GB (1); DE (1)