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

NCT05195658 | Recruiting

• 1 other identifier: SAFEGUARD-STROKE
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, single-center, clinical registry of patients with acute stroke of carotid artery bifurcation origin undergoing endovascular treatment using the Micronet-covered CGUARD Stent to seal the culprit lesion under proximal cerebral protection (by transient flow reversal using balloon catheter such as the MoMa or FlowGate) with thrombus retrieval achieved through active aspiration ± stentriever use. A study involving clinical and cerebrovascular imaging data evaluation in consecutive patients with acute stroke of carotid artery bifurcation origin, presenting in the time-window and/or cerebral tissue window allowing guideline-indicated reperfusion by interventional management. A registry of consecutive patients with the study condition. An open-label study, without randomization - a single arm, single-center study in John Paul II Hospital in Krakow, Poland.

Conditions

Carotid Artery Stenosis; Acute Ischemic Stroke

Keywords

Carotid Stenosis; Acute Ischemic Stroke; Anesthesia; Imaging; Interventional Management; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• Freedom from poor clinical status at 90 days

  Freedom from poor clinical status (expressed as modified Rankin score, mRS \>2) at 90 days

  90 days from index procedure

Secondary Outcomes (21)

• Freedom from major clinical complications comprising MACNE (major adverse cardiovascular or neurologic event) at 30 days

  At 30 days from index procedure

• Freedom from major clinical complications comprising MACNE at 90 days

  At 90 days from index procedure

• Freedom from major clinical complications comprising MACNE at 12 months

  At 12 months from index procedure

• Procedural success rate for carotid intervention

  Periprocedural

• Technical success rate for carotid intervention

  At procedure completion

Study Arms (1)

Acute ischemic stroke with culprit lesion at the carotid bifurcation

Consecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, accepted for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines

Device: Thrombectomy and Stenting under neuroprotection

Interventions

Thrombectomy and Stenting under neuroprotection DEVICE

Endovascular management of the stroke culprit lesion using the Micronet-covered CGuard stent under neuroprotection. Transient flow achieved using a balloon guide catheter (e.g. MoMa or FlowGate) with additional active aspiration/s at key procedural steps. If indicated, targeted (extra- and/or intracranial) thrombus retrieval using either a thrombus aspiration device and/or a stentriever. Use of pharmaco-sedation versus general anesthesia is as indicated clinically and is according to the anesthesiologist and operator decision - according to routine practice in the center. Patient pre-procedural (including imaging and other diagnostic work-up), procedural, and post-procedural (including blood pressure tight control) management, including pharmacotherapy, are according to the AHA/ASA stroke management guidelines and the devices IFUs. Overall study patient management and intervention is according to routine clinical practice in the study center.

Acute ischemic stroke with culprit lesion at the carotid bifurcation

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

All-comers clinical registry of consecutive patients with acute ischemic stroke culprit lesion at the carotid bifurcation, cleared for emergent interventional management by the NeuroVascular Team Committee according to stroke management guidelines.

You may qualify if:

• Consecutive patients with acute ischemic stroke with carotid artery bifurcation stenosis/occlusion as culprit lesion.
• Clinical picture of acute ischemic stroke, stroke-in-evolution, or crescendo TIAs.
• Patient eligible for endovascular stroke therapy according to AHA/ASA stroke management and accepted for emergent stroke intervention by the local NeuroVascular Team Committee according to local standard of practice.
• Signed informed consent form to participate in the study (obtained at the point of first feasibility; note that live-saving procedure track may be executed for performing intervention according to local regulations and routine practice in the center)
• Consent to (routinely performed in this group of patients) follow-up visits that may include imaging as per routine practice in the study center and as clinically indicated.

You may not qualify if:

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

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead

Study Sites (1)

Department of Cardiac and Vascular Diseases, John Paul II Hospital

Krakow, 31-202, Poland

RECRUITING

Related Publications (2)

• Tekieli L, Afanasjev A, Mazgaj M, Borodetsky V, Sievert K, Ruzsa Z, Knapik M, Sirvinskas A, Mazurek A, Dzierwa K, Sanczuk T, Mosenko V, Urbanczyk-Zawadzka M, Trystula M, Paluszek P, Wiewiorka L, Stefaniak J, Pieniazek P, Slautaite I, Kwiatkowski T, Mackevicius A, Teitcher M, Sievert H, Grunwald IQ, Musialek P. A multi-center study of the MicroNET-covered stent in consecutive patients with acute carotid-related stroke: SAFEGUARD-STROKE. Postepy Kardiol Interwencyjnej. 2024 Jun;20(2):172-193. doi: 10.5114/aic.2024.140963. Epub 2024 Jun 30.

  PMID: 39022700 DERIVED

• Tekieli L, Dzierwa K, Grunwald IQ, Mazurek A, Urbanczyk-Zawadzka M, Wiewiorka L, Banys RP, Dabrowski W, Podlasek A, Weglarz E, Stefaniak J, Nizankowski RT, Musialek P. Outcomes in acute carotid-related stroke eligible for mechanical reperfusion: SAFEGUARD-STROKE Registry. J Cardiovasc Surg (Torino). 2024 Jun;65(3):231-248. doi: 10.23736/S0021-9509.24.13093-5.

  PMID: 39007556 DERIVED

MeSH Terms

Conditions

Carotid Stenosis; Ischemic Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Piotr Musialek, MD, DPhil

  Department of Cardiac and Vascular Diseases, John Paul II Hospital in Krakow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Musialek, MD, DPhil

CONTACT

+48126142287; pmusialek@szpitaljp2.krakow.pl

Lukasz Tekieli, MD, PhD

CONTACT

+48126143501; luk.tekieli@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 19, 2022
• Study Start: January 30, 2022
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

PL (1)