Carotid Artery DiseasesOPTIMANCT04234854
OPTIMAl Endovascular Exclusion of Consecutive Patient High-risk Carotid Plaque Using the MicroNet Covered Stent
An observational study of Carotid Artery Diseases, run by John Paul II Hospital, Krakow at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases
- What is being tested?
- Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 31 Jan 2020to Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, Maloplska, 31-202
Piotr Musialek, Prof, +48126142287, p.musialek@szpitaljp2.krakow.pl
About this study
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
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.
Read the 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).
- Conditions
- Carotid Artery Diseases
- Being tested
- Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent
- Keywords
- Stenting
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Carotid Artery Stenting | Consecutive patients older than 18 yrs with symptomatic carotid artery stenosis qualified for endovascular revascularization. Receives: Diagnostic Test: Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from plaque prolapse
Freedom from plaque prolapse defined as observation of plaque inside the stent lumen after completion of the CAS procedure by IVUS assessment (Kotsugi 2017).
Measured: During index procedure
Secondary outcomes (9)
Procedural success
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
Measured: During index procedure
IVUS interrogation success
IVUS interrogation with an effective IVUS probe removal in absence of any clinical complications
Measured: During index procedure
Endovascular lumen reconstruction
Freedom from plaque prolapse plus minimal in-stent area >50% ICA reference area
Measured: During index procedure
Periprocedural MACCE
Death, stroke, myocardial infarction until discharge or up to 24 hours
Measured: Until discharge or up to 24 hours
30 days MACCE
Death, stroke, myocardial infarction until 30 days
Measured: 30 days
Any periprocedural complications
Any complications occurring until discharge or 24 hours whichever comes first
Measured: Until discharge or up to 24 hours
Ipsilateral stroke between 31 days and 12 months after the procedure
Ipsilateral stroke between 31 days and 12 months after the procedure
Measured: Between 31 days and 12 months after the procedure
Duplex UltraSound (DUS) at 30 days
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) recorded by Duplex Doppler at 30±5 days after the procedure
Measured: 30 days
Duplex UltraSound (DUS) at 12 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) recorded by Duplex Doppler at 12 months after the procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start31 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Collaborators
- InspireMD
- Responsible party
- Sponsor
- Investigators
- Piotr Musialek, MD, PhD, Study chair, Department of Cardiac and Vascular Diseases, The John Paul II Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234854
- Sponsor's protocol ID
- OPTIMA
- Acronym
- OPTIMA
- Status last verified
- Oct 2021
- First submitted
- 16 Jan 2020
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kotsugi M, Takayama K, Myouchin K, Wada T, Nakagawa I, Nakagawa H, Taoka T, Kurokawa S, Nakase H, Kichikawa K. Carotid Artery Stenting: Investigation of Plaque Protrusion Incidence and Prognosis. JACC Cardiovasc Interv. 2017 Apr 24;10(8):824-831. doi: 10.1016/j.jcin.2017.01.029.
PubMed 28427600Musialek P, Pieniazek P, Tracz W, Tekieli L, Przewlocki T, Kablak-Ziembicka A, Motyl R, Moczulski Z, Stepniewski J, Trystula M, Zajdel W, Roslawiecka A, Zmudka K, Podolec P. Safety of embolic protection device-assisted and unprotected intravascular ultrasound in evaluating carotid artery atherosclerotic lesions. Med Sci Monit. 2012 Feb;18(2):MT7-18. doi: 10.12659/msm.882452.
PubMed 22293887Clark DJ, Lessio S, O'Donoghue M, Schainfeld R, Rosenfield K. Safety and utility of intravascular ultrasound-guided carotid artery stenting. Catheter Cardiovasc Interv. 2004 Nov;63(3):355-62. doi: 10.1002/ccd.20188.
PubMed 15505835Bandyk DF, Armstrong PA. Use of intravascular ultrasound as a "Quality Control" technique during carotid stent-angioplasty: are there risks to its use? J Cardiovasc Surg (Torino). 2009 Dec;50(6):727-33.
PubMed 19935603Hitchner E, Zhou W. Utilization of Intravascular Ultrasound during Carotid Artery Stenting. Int J Angiol. 2015 Sep;24(3):185-8. doi: 10.1055/s-0035-1556081. Epub 2015 Jul 10.
PubMed 26417186Musialek P, Hopf-Jensen S. Commentary: Carotid Artery Revascularization for Stroke Prevention: A New Era. J Endovasc Ther. 2017 Feb;24(1):138-148. doi: 10.1177/1526602816671263. Epub 2016 Oct 13. No abstract available.
PubMed 27733691Schofer J, Musialek P, Bijuklic K, Kolvenbach R, Trystula M, Siudak Z, Sievert H. A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1229-1234. doi: 10.1016/j.jcin.2015.04.016.
PubMed 26292586Musialek P, Mazurek A, Trystula M, Borratynska A, Lesniak-Sobelga A, Urbanczyk M, Banys RP, Brzychczy A, Zajdel W, Partyka L, Zmudka K, Podolec P. Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard MicroNet-covered embolic prevention stent system. EuroIntervention. 2016 Aug 5;12(5):e658-70. doi: 10.4244/EIJY16M05_02.
PubMed 27180302Ruffino MA, Faletti R, Fronda M, Gatti M, Bergamasco L, Gibello L, Varetto G, Righi D, Rispoli P, Fonio P. Early Embolization After Carotid Artery Stenting with Mesh-Covered Stent: Role of Diffusion-Weighted Magnetic Resonance Imaging as Pre-procedural Predictor and Discriminant Between Intra- and Post-procedural Events. Cardiovasc Intervent Radiol. 2019 Jun;42(6):812-819. doi: 10.1007/s00270-019-02173-1. Epub 2019 Feb 19.
PubMed 30783778Speziale F, Capoccia L, Sirignano P, Mansour W, Pranteda C, Casana R, Setacci C, Accrocca F, Alberti D, de Donato G, Ferri M, Gaggiano A, Galzerano G, Ippoliti A, Mangialardi N, Pratesi G, Ronchey S, Ruffino A, Siani A, Spinazzola A, Sponza M. Thirty-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard MicroNet-covered Embolic Prevention System in real-world multicentre clinical practice: the IRON-Guard study. EuroIntervention. 2018 Feb 20;13(14):1714-1720. doi: 10.4244/EIJ-D-17-00008.
PubMed 28485278Musialek P, Grunwald IQ. How asymptomatic is "asymptomatic" carotid stenosis? Resolving fundamental confusion(s) - and confusions yet to be resolved. Pol Arch Intern Med. 2017 Nov 30;127(11):718-719. doi: 10.20452/pamw.4157. Epub 2017 Nov 30. No abstract available.
PubMed 29192895Stabile E, Sannino A, Schiattarella GG, Gargiulo G, Toscano E, Brevetti L, Scudiero F, Giugliano G, Perrino C, Trimarco B, Esposito G. Cerebral embolic lesions detected with diffusion-weighted magnetic resonance imaging following carotid artery stenting: a meta-analysis of 8 studies comparing filter cerebral protection and proximal balloon occlusion. JACC Cardiovasc Interv. 2014 Oct;7(10):1177-83. doi: 10.1016/j.jcin.2014.05.019. Epub 2014 Sep 17.
PubMed 25240544Wissgott C, Schmidt W, Brandt-Wunderlich C, Behrens P, Andresen R. Clinical Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent. J Endovasc Ther. 2017 Feb;24(1):130-137. doi: 10.1177/1526602816671134. Epub 2016 Oct 13.
PubMed 27733689Stabile E, de Donato G, Musialek P, De Loose K, Nerla R, Sirignano P, Chianese S, Mazurek A, Tesorio T, Bosiers M, Setacci C, Speziale F, Micari A, Esposito G. Use of Dual-Layered Stents in Endovascular Treatment of Extracranial Stenosis of the Internal Carotid Artery: Results of a Patient-Based Meta-Analysis of 4 Clinical Studies. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2405-2411. doi: 10.1016/j.jcin.2018.06.047.
PubMed 30522670Casana R, Tolva V, Odero A Jr, Malloggi C, Paolucci A, Triulzi F, Silani V. Safety and Efficacy of the New Micromesh-Covered Stent CGuard in Patients Undergoing Carotid Artery Stenting: Early Experience From a Single Centre. Eur J Vasc Endovasc Surg. 2017 Dec;54(6):681-687. doi: 10.1016/j.ejvs.2017.09.015. Epub 2017 Oct 28.
PubMed 29089282
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04234854
- Acronym / sponsor ID
- OPTIMA / OPTIMA
- Conditions
- Carotid Artery Diseases
- Keywords
- Stenting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Collaborators
- InspireMD
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Artery Stenting | – | Diagnostic Test: Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stentConsecutive patients older than 18 yrs with symptomatic carotid artery stenosis qualified for endovascular revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stentIVUS will be performed after stent postdilatation to determine the incidence of plaque prolapse. Additionally optimizing stent expansion with IVUS is left at operator discretion. | Diagnostic test | Carotid Artery Stenting |
Primary outcome
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).
9 secondary outcomes
Procedural success
Time frame: During index procedure
IVUS interrogation success
Time frame: During index procedure
Endovascular lumen reconstruction
Time frame: During index procedure
Periprocedural MACCE
Time frame: Until discharge or up to 24 hours
30 days MACCE
Time frame: 30 days
Any periprocedural complications
Time frame: 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
Duplex UltraSound (DUS) at 30 days
Time frame: 30 days
Duplex UltraSound (DUS) at 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Background: PubMed 28427600Kotsugi M, Takayama K, Myouchin K, Wada T, Nakagawa I, Nakagawa H, Taoka T, Kurokawa S, Nakase H, Kichikawa K. Carotid Artery Stenting: Investigation of Plaque Protrusion Incidence and Prognosis. JACC Cardiovasc Interv. 2017 Apr 24;10(8):824-831. doi: 10.1016/j.jcin.2017.01.029.
- Background: PubMed 22293887Musialek P, Pieniazek P, Tracz W, Tekieli L, Przewlocki T, Kablak-Ziembicka A, Motyl R, Moczulski Z, Stepniewski J, Trystula M, Zajdel W, Roslawiecka A, Zmudka K, Podolec P. Safety of embolic protection device-assisted and unprotected intravascular ultrasound in evaluating carotid artery atherosclerotic lesions. Med Sci Monit. 2012 Feb;18(2):MT7-18. doi: 10.12659/msm.882452.
- Background: PubMed 15505835Clark DJ, Lessio S, O'Donoghue M, Schainfeld R, Rosenfield K. Safety and utility of intravascular ultrasound-guided carotid artery stenting. Catheter Cardiovasc Interv. 2004 Nov;63(3):355-62. doi: 10.1002/ccd.20188.
- Background: PubMed 19935603Bandyk DF, Armstrong PA. Use of intravascular ultrasound as a "Quality Control" technique during carotid stent-angioplasty: are there risks to its use? J Cardiovasc Surg (Torino). 2009 Dec;50(6):727-33.
- Background: PubMed 26417186Hitchner E, Zhou W. Utilization of Intravascular Ultrasound during Carotid Artery Stenting. Int J Angiol. 2015 Sep;24(3):185-8. doi: 10.1055/s-0035-1556081. Epub 2015 Jul 10.
- Background: PubMed 27733691Musialek P, Hopf-Jensen S. Commentary: Carotid Artery Revascularization for Stroke Prevention: A New Era. J Endovasc Ther. 2017 Feb;24(1):138-148. doi: 10.1177/1526602816671263. Epub 2016 Oct 13. No abstract available.
- Background: PubMed 26292586Schofer J, Musialek P, Bijuklic K, Kolvenbach R, Trystula M, Siudak Z, Sievert H. A Prospective, Multicenter Study of a Novel Mesh-Covered Carotid Stent: The CGuard CARENET Trial (Carotid Embolic Protection Using MicroNet). JACC Cardiovasc Interv. 2015 Aug 17;8(9):1229-1234. doi: 10.1016/j.jcin.2015.04.016.
- Background: PubMed 27180302Musialek P, Mazurek A, Trystula M, Borratynska A, Lesniak-Sobelga A, Urbanczyk M, Banys RP, Brzychczy A, Zajdel W, Partyka L, Zmudka K, Podolec P. Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard MicroNet-covered embolic prevention stent system. EuroIntervention. 2016 Aug 5;12(5):e658-70. doi: 10.4244/EIJY16M05_02.
- Background: PubMed 30783778Ruffino MA, Faletti R, Fronda M, Gatti M, Bergamasco L, Gibello L, Varetto G, Righi D, Rispoli P, Fonio P. Early Embolization After Carotid Artery Stenting with Mesh-Covered Stent: Role of Diffusion-Weighted Magnetic Resonance Imaging as Pre-procedural Predictor and Discriminant Between Intra- and Post-procedural Events. Cardiovasc Intervent Radiol. 2019 Jun;42(6):812-819. doi: 10.1007/s00270-019-02173-1. Epub 2019 Feb 19.
- Background: PubMed 28485278Speziale F, Capoccia L, Sirignano P, Mansour W, Pranteda C, Casana R, Setacci C, Accrocca F, Alberti D, de Donato G, Ferri M, Gaggiano A, Galzerano G, Ippoliti A, Mangialardi N, Pratesi G, Ronchey S, Ruffino A, Siani A, Spinazzola A, Sponza M. Thirty-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuard MicroNet-covered Embolic Prevention System in real-world multicentre clinical practice: the IRON-Guard study. EuroIntervention. 2018 Feb 20;13(14):1714-1720. doi: 10.4244/EIJ-D-17-00008.
- Background: PubMed 29192895Musialek P, Grunwald IQ. How asymptomatic is "asymptomatic" carotid stenosis? Resolving fundamental confusion(s) - and confusions yet to be resolved. Pol Arch Intern Med. 2017 Nov 30;127(11):718-719. doi: 10.20452/pamw.4157. Epub 2017 Nov 30. No abstract available.
- Background: PubMed 25240544Stabile E, Sannino A, Schiattarella GG, Gargiulo G, Toscano E, Brevetti L, Scudiero F, Giugliano G, Perrino C, Trimarco B, Esposito G. Cerebral embolic lesions detected with diffusion-weighted magnetic resonance imaging following carotid artery stenting: a meta-analysis of 8 studies comparing filter cerebral protection and proximal balloon occlusion. JACC Cardiovasc Interv. 2014 Oct;7(10):1177-83. doi: 10.1016/j.jcin.2014.05.019. Epub 2014 Sep 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Musialek, MD, PhD study chair
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases, run by John Paul II Hospital, Krakow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Musialek, Prof. (+48126142287, p.musialek@szpitaljp2.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from plaque prolapse (time frame: During index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234854, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.