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

October 19, 2021 updated by: John Paul II Hospital, Krakow

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Maloplska
      • Kraków, Maloplska, Poland, 31-202
        • Recruiting
        • Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
During index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During index procedure
IVUS interrogation success
Time Frame: During index procedure
IVUS interrogation with an effective IVUS probe removal in absence of any clinical complications
During index procedure
Endovascular lumen reconstruction
Time Frame: During index procedure
Freedom from plaque prolapse plus minimal in-stent area >50% ICA reference area
During index procedure
Periprocedural MACCE
Time Frame: Until discharge or up to 24 hours
Death, stroke, myocardial infarction until discharge or up to 24 hours
Until discharge or up to 24 hours
30 days MACCE
Time Frame: 30 days
Death, stroke, myocardial infarction until 30 days
30 days
Any periprocedural complications
Time Frame: Until discharge or up to 24 hours
Any complications occurring until discharge or 24 hours whichever comes first
Until discharge or up to 24 hours
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
Between 31 days and 12 months after the procedure
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
30 days
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Paul II Hospital, Krakow

Collaborators

InspireMD

Investigators

  • Study Chair: Piotr Musialek, MD, PhD, Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

January 16, 2020

First Submitted That Met QC Criteria

January 16, 2020

First Posted (Actual)

January 21, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTIMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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