Actively Recruiting

Age: 18Years +
All Genders
ID05195658

Acute Stroke of Carotid Artery Bifurcation Origin Treated With Use of the Micronet-covered CGuard Stent Under Transient Flow Reversal Linked With Thrombus Retrieval: SAFEGUARD-STROKE Study

Led by John Paul II Hospital, Krakow · Updated on 2022-02-28

20

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of the Micronet-covered CGuard stent to treat patients with acute stroke caused by blockage at the carotid artery bifurcation. This type of stroke is challenging to treat and often has poor outcomes with standard intravenous clot-busting treatments. The study aims to assess this device in an urgent, real-world setting where current treatment options and timing for intervention are not well established. This is a single-center, open-label registry study including consecutive patients who qualify for endovascular management. The treatment involves placing the Micronet-covered stent to seal the clot-causing lesion while using proximal cerebral protection through transient flow reversal achieved by balloon catheters like MoMa or FlowGate. When needed, clot removal from the arteries supplying the brain is performed using aspiration devices or stentrievers. Patient management, including anesthesia choice and medications, follows established stroke guidelines and routine clinical practice at the study center. Participants will undergo clinical evaluations and brain and blood vessel imaging such as CT or MRI at presentation and during follow-up. The study will track safety and effectiveness outcomes including clinical status at 90 days, procedural success, stroke recurrence, and complications over up to 5 years. Follow-up visits may include imaging and assessments as per routine care. The total participation duration depends on each patient’s clinical course and follow-up schedule.

CONDITIONS

Brief Title

Acute Stroke of CArotid Artery Bifurcation Origin Treated With Use oF the MicronEt-covered CGUARD (SAFEGUARD-STROKE)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis or occlusion as the culprit lesion
  • Clinical signs of acute ischemic stroke, stroke-in-evolution, or crescendo transient ischemic attacks (TIAs)
  • Eligible for endovascular stroke therapy according to AHA/ASA guidelines and accepted by the local NeuroVascular Team Committee
  • Signed informed consent form to participate in the study
  • Consent to follow-up visits including imaging as clinically indicated
Not Eligible

You will not qualify if you...

  • Known stroke cause other than the carotid bifurcation lesion
  • Lack of an effective endovascular route needed for intervention
  • Any known contraindications to stroke endovascular management

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single procedure with immediate post-procedural care

Participants undergo an endovascular procedure using the Micronet-covered CGuard stent under neuroprotection to treat the stroke lesion at the carotid artery bifurcation. This includes transient flow reversal with a balloon guide catheter and, if indicated, thrombus retrieval using aspiration or a stentriever. Management follows routine clinical practice and stroke guidelines.

1 procedural visit (in-person)

Long-term Monitoring

Duration - Up to 5 years post-procedure

Participants are monitored over time to assess clinical outcomes, complications, and stent performance according to standard follow-up protocols.

Follow-up visits at 30 days, 90 days, 1 year, and annually up to 5 years

Trial Site Locations

Total: 1 location

1

Department of Cardiac and Vascular Diseases, John Paul II Hospital

Krakow, Poland, 31-202

Actively Recruiting

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Research Team

P

Piotr Musialek, MD, DPhil

L

Lukasz Tekieli, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE.

Lukasz Tekieli, Andrej Afanasjev, Maciej Mazgaj...

https://pubmed.ncbi.nlm.nih.gov/39022700