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OPTIMAl Endovascular Exclusion of Consecutive Patient High-risk Carotid Plaque Using the MicroNet Covered Stent (OPTIMA)

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ClinicalTrials.gov Identifier: NCT04234854
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
InspireMD
Information provided by (Responsible Party):
John Paul II Hospital, Krakow

Brief Summary:
Prospective, multicentric, multispecialty, international, open-label, single arm study using per-protocol intravascular ultrasound [IVUS, 20MHz electronic phase-array transducer] to document the procedure result of an effective plaque exclusion from the vessel lumen.

Condition or disease Intervention/treatment
Carotid Artery Diseases Diagnostic Test: Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent

Detailed Description:

Investigator initiated, academic, single arm, open-label, non-randomized, prospective, multicenter, multispecialty trial of CGuard™ use in all-comer population of consecutive patients with carotid stenosis related cerebral symptoms (TIA, stroke, retinal TIA, retinal stroke) or signs of ipsilateral brain injury on MRI or CT imaging.

The main objective of this observational study is to evaluate an incidence of residual plaque prolapse after carotid stenting using the study device.

Study Rationale In conventional carotid stents, plaque prolapse (PP) on intravascular imaging had been determined to be strongly associated with new post-procedural diffusion-weighted magnetic resonance lesions on cerebral imaging and with increased ischaemic stroke incidence. A significant increase in PP susceptibility was observed with unstable carotid plaque, pointing to the limitations of conventional CAS in unstable carotid plaques, such as symptomatic and increased-spontaneous-symptoms-risk lesions.

This is reflected in current guidelines that provide a higher recommendation class to surgical management (CEA) rather than CAS for symptomatic lesions.

Circumstantial evidence indicates that the novel carotid stent covered with MicroNET (CGuard EPS) may be an optimal device for effective carotid plaque sequestration (that may be particularly relevant in high-risk plaques) - but no systematic study has been performed thus far.

Because of the increasing evidence that not only clinical symptoms (that may be related to for instance the affection of dominant vs. non-dominant haemisphere) but also signs of ipisilateral cerebral infarct/s are a hallmark of high-risk plaque and are associated with adverse prognosis, and because that neurology increasingly uses the term "symptomatic" to refer to carotid stenosis associated with clinically silent ipisilateral cerebral infarct/s, the present study will enroll both patients with clinical symptoms of cerebral ischaemia in relation to carotid stenosis and those with (clinically silent) signs of ipsilateral injury such as ischemic focus/foci on CT or MRI/DW-MRI).

As previously demonstrated, clinically significant/relevant PP is that depicted by IVUS (with angiography, on the one hand, being not sensitive enough and OCT, on the other, being possibly too sensitive).

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OPTIMAl Endovascular Exclusion of High-risk Carotid Plaque Using the CGuard™ Stent in Patients With Symptoms or Signs of Carotid Stenosis-related Brain Injury: IVUS Controlled Investigator Initiated Multcentric Multi-specialty Study
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Carotid Artery Stenting
Consecutive patients older than 18 yrs with symptomatic carotid artery stenosis qualified for endovascular revascularization.
Diagnostic Test: Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent
IVUS will be performed after stent postdilatation to determine the incidence of plaque prolapse. Additionally optimizing stent expansion with IVUS is left at operator discretion.




Primary Outcome Measures :
  1. Freedom from plaque prolapse [ Time Frame: During index procedure ]
    Freedom from plaque prolapse defined as observation of plaque inside the stent lumen after completion of the CAS procedure by IVUS assessment (Kotsugi 2017).


Secondary Outcome Measures :
  1. Procedural success [ Time Frame: During index procedure ]
    stent delivery and implantation in absence of an intra-procedural clinical major adverse event, with no more than 30% residual diameter stenosis by on-site QCA, and successful withdrawal of the stent delivery and neuroprotection system

  2. IVUS interrogation success [ Time Frame: During index procedure ]
    IVUS interrogation with an effective IVUS probe removal in absence of any clinical complications

  3. Endovascular lumen reconstruction [ Time Frame: During index procedure ]
    Freedom from plaque prolapse plus minimal in-stent area >50% ICA reference area

  4. Periprocedural MACCE [ Time Frame: Until discharge or up to 24 hours ]
    Death, stroke, myocardial infarction until discharge or up to 24 hours

  5. 30 days MACCE [ Time Frame: 30 days ]
    Death, stroke, myocardial infarction until 30 days

  6. Any periprocedural complications [ Time Frame: Until discharge or up to 24 hours ]
    Any complications occurring until discharge or 24 hours whichever comes first

  7. Ipsilateral stroke between 31 days and 12 months after the procedure [ Time Frame: Between 31 days and 12 months after the procedure ]
    Ipsilateral stroke between 31 days and 12 months after the procedure

  8. Duplex UltraSound (DUS) at 30 days [ Time Frame: 30 days ]
    Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) recorded by Duplex Doppler at 30±5 days after the procedure

  9. Duplex UltraSound (DUS) at 12 months [ Time Frame: 12 months ]
    Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) recorded by Duplex Doppler at 12 months after the procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive clinically-symptomatic patients (ipsilateral cerebral or retinal stroke or TIA with the preceding 6 months) with atherosclerotic de novo carotid artery stenosis causing at least 50% lumen reduction by quantitative carotid catheter angiography (QCA) or carotid stenosis of at least 50% lumen reduction by QCA in relation to documented ipsilateral ischaemic brain lesions/infarct on CT or MRI.
Criteria

Inclusion Criteria:

  • All consecutive patients with clinically symptomatic carotid stenosis , or carotid stenosis associated with ipisilateral cerebral ischemic infarct/s on CT or MRI/DWI imaging, referred and accepted by the study center for CAS as per local standard referral pathways and study center routine.
  • Patient informed consent to participate.
  • Patient accepts follow-up scheme and consents to follow-up visits.

Exclusion Criteria:

  • Lack of indication to carotid revascularization as per current ESC/ESVS Guidelines, or any clinical or angiographic or other contraindication to CAS (such as renal failure defined as creatinine level > 2.5 mg/dL or eGFR <20 ml/kg min, or incompatibility with DAPT).
  • Surgery within the preceding 30 days or planned surgery within 30 days after CAS.
  • Life expectancy <1 year (eg. neoplastic disease).
  • MI within 72h prior to CAS.
  • Known coagulopathy.
  • History of cerebral stroke with documented/known cause other than carotid disease.
  • Atrial fibrillation or flutter.
  • Any known cause for potential cerebral embolization different than carotid stenosis.
  • History of intracranial bleeding.
  • Any contraindications to as per IFU study device implantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234854


Contacts
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Contact: Piotr Musialek, Prof. +48126142287 p.musialek@szpitaljp2.krakow.pl

Locations
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Poland
Department of Cardiac and Vascular Diseases, The John Paul II Hospital Recruiting
Kraków, Maloplska, Poland, 31-202
Contact: Piotr Musialek, Prof    +48126142287    p.musialek@szpitaljp2.krakow.pl   
Sponsors and Collaborators
John Paul II Hospital, Krakow
InspireMD
Investigators
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Study Chair: Piotr Musialek, MD, PhD Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Publications:
Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Röther J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I, Document Reviewers, Widimsky P, Kolh P, Agewall S, Bueno H, Coca A, De Borst GJ, Delgado V, Dick F, Erol C, Ferrini M, Kakkos S, Katus HA, Knuuti J, Lindholt J, Mattle H, Pieniazek P, Piepoli MF, Scheinert D, Sievert H, Simpson I, Sulzenko J, Tamargo J, Tokgozoglu L, Torbicki A, Tsakountakis N, Tuñón J, Vega de Ceniga M, Windecker S, Zamorano JL. Editor's Choice - 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):305-368. doi: 10.1016/j.ejvs.2017.07.018. Epub 2017 Aug 26. Review.

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Responsible Party: John Paul II Hospital, Krakow
ClinicalTrials.gov Identifier: NCT04234854    
Other Study ID Numbers: OPTIMA
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Paul II Hospital, Krakow:
Stenting
Additional relevant MeSH terms:
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Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases