Carotid StenosisNCT03303430
Microembolisation After Carotid Revascularisation
An observational study of Carotid Stenosis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is recognized as an important outcome measure for carotid revascularization procedures such as carotid stenting (CAS) or carotid endarterectomy (CEA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Carotid Stenosis
- What is being tested?
- MRI
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Mar 2017to 30 Mar 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Screening of a carotid plaque is part of a routine procedure for patients admitted for stroke or TIA and includes ultrasound, CT-scan and MRI. Patients presenting a symptomatic or asymptomatic carotid stenosis are routinely discussed within a multidisciplinary meeting and the most appropriate therapeutic option is decided. For some patients, surgery and stenting are equivalent options. In that case, the patient may be a candidate for the present study
Who may be able to join
- Patients presenting a symptomatic (ipsilateral ischemic stroke, TIA located in the carotid artery territory or retinal ischemia) carotid stenosis between 50% and 99% (according to NASCET and ECST criteria)
- Patients presenting an asymptomatic carotid stenosis between 60% and 99% (according to NASCET and ECST criteria) Patients who accept the informed consent
Who cannot join
- Important neurological deficit with NIHSS >7 (or severe aphasia) at time of inclusion
- Previous known cognitive impairment
- Pregnancy
- Presence of contraindication based on ground of multidisciplinary team decision:
- For surgery:
- High bifurcation Intracranial extension of the carotid stenosis Patients with tandem lesions High suspicion of severe siphon stenosis Patients with previous irradiation of the cervical region Patients with restenosis after endarterectomy
Show all 10Show fewer
- For stenting; Excessive arch vessel or carotid artery tortuosity and in particular presence tortuosity ≤90 degrees in the cervical segment Excessive aortic arch plaque burden Patients older than 70 years Unfavourable anatomic disposition as described above Co-morbidities that may preclude the use of a periprocedural dual antiplatelet regime.
- For CT-scan Iodine allergy Renal insufficiency
- For MRI Pacemaker Any other metallic implants Claustrophobia
- For ultrasound Bad quality ultrasound (patient morphology or equipments
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Fisch Loraine
Geneva, 1205
Loraine Fisch, +41795533837, loraine.fisch@hcuge.ch
Roman Sztajzel, MD, +41795533807, roman.sztajzel@hcuge.ch
About this study
Official title: Correlation Between Cerebral Microembolisation and Plaque Characteristics After Carotid Revascularization
Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is recognized as an important outcome measure for carotid revascularization procedures such as carotid stenting (CAS) or carotid endarterectomy (CEA). In fact, cerebral microembolisation occurring during revascularization procedures is associated with an increased risk of peri- and post-procedural stroke, transient ischemic attack as well as neurocognitive decline. Carotid artery stenting is a less invasive alternative to endarterectomy to treat symptomatic or asymptomatic carotid stenosis. Large randomized clinical trials showed a higher periprocedural risk of non-disabling stroke with CAS and a higher periprocedural risk of myocardial infarction, cranial nerve palsy, and access site hematoma with CEA.
However little is known regarding the correlation between the morphological characteristics of the carotid plaque and the occurrence of microembolisation during the procedure and between microembolisation and midterm cognitive impairment. A few studies suggest that plaque morphology may be an important determinant for the increased risk of microembolisation. These studies however have mainly investigated microembolisation occurring during CAS and exploratory studies comparing the two procedures are still lacking.
The purpose of the present study is to determine the correlation between the morphological characteristics of the carotid plaque and cerebral microembolisation either after carotid stenting or after carotid endarterectomy in patients with symptomatic or asymptomatic carotid disease.
- Conditions
- Carotid Stenosis
- Being tested
- MRI
- Keywords
- cerebral microembolisation, plaque characteristics
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Diffusion weighted imaging 24 hours after revascularisation
| Study group | Role | What they receive |
|---|---|---|
| Surgery group | This patient's group will benefit from a endarteriectomy in order to treat their carotid stenosis. Receives: Diagnostic Test: MRI | |
| Stenting group | This patient's group will benefit from a stenting of their carotid in order to treat their stenosis. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral microembolisation
the presence of at least 1 new hyperintense DWI lesion on the MRI realized within the 24 hours after procedure and will be correlated to the different characteristics of the carotid plaque evaluation.
Measured: 24 hours
Secondary outcomes (1)
Neuropsychological assessment
Number and locations (watershed versus territorial) of the microembolisation will be dentified on DW-MRI and will be correlated to the neuropsychological changes after the procedure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start30 Mar 2017
- Primary completion30 Mar 2019 (estimated)
- Study completion30 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loraine Fisch, University Hospital, Geneva
- Investigators
- Loraine Fisch, Principal investigator, Junior consultant, neurovascular unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03303430
- Sponsor's protocol ID
- PLASTIS
- Status last verified
- Oct 2017
- First submitted
- 2 Oct 2017
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, Duggirala MK, Erwin PJ, Montori VM, Gloviczki P. A systematic review and meta-analysis of the treatments of varicose veins. J Vasc Surg. 2011 May;53(5 Suppl):49S-65S. doi: 10.1016/j.jvs.2011.02.031.
PubMed 21536173Bonati LH, Fraedrich G; Carotid Stenting Trialists' Collaboration. Age modifies the relative risk of stenting versus endarterectomy for symptomatic carotid stenosis--a pooled analysis of EVA-3S, SPACE and ICSS. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):153-8. doi: 10.1016/j.ejvs.2011.01.001. Epub 2011 Jan 26.
PubMed 21269847Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
PubMed 24788967Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J, Nederkoorn PJ, Macdonald S, Gaines PA, Waaijer A, Stierli P, Jager HR, Lyrer PA, Kappelle LJ, Wetzel SG, van der Lugt A, Mali WP, Brown MM, van der Worp HB, Engelter ST; ICSS-MRI study group. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol. 2010 Apr;9(4):353-62. doi: 10.1016/S1474-4422(10)70057-0. Epub 2010 Feb 25.
PubMed 20189458Gensicke H, van der Worp HB, Nederkoorn PJ, Macdonald S, Gaines PA, van der Lugt A, Mali WP, Lyrer PA, Peters N, Featherstone RL, de Borst GJ, Engelter ST, Brown MM, Bonati LH; ICSS-MRI Substudy Investigators. Ischemic brain lesions after carotid artery stenting increase future cerebrovascular risk. J Am Coll Cardiol. 2015 Feb 17;65(6):521-9. doi: 10.1016/j.jacc.2014.11.038.
PubMed 25677309Rothwell PM, Slattery J, Warlow CP. Clinical and angiographic predictors of stroke and death from carotid endarterectomy: systematic review. BMJ. 1997 Dec 13;315(7122):1571-7. doi: 10.1136/bmj.315.7122.1571.
PubMed 9437274Biasi GM, Froio A, Diethrich EB, Deleo G, Galimberti S, Mingazzini P, Nicolaides AN, Griffin M, Raithel D, Reid DB, Valsecchi MG. Carotid plaque echolucency increases the risk of stroke in carotid stenting: the Imaging in Carotid Angioplasty and Risk of Stroke (ICAROS) study. Circulation. 2004 Aug 10;110(6):756-62. doi: 10.1161/01.CIR.0000138103.91187.E3. Epub 2004 Jul 26.
PubMed 15277320Varetto G, Gibello L, Faletti R, Gattuso A, Garneri P, Castagno C, Quaglino S, Rispoli P. Contrast-enhanced ultrasound to predict the risk of microembolization during carotid artery stenting. Radiol Med. 2015 Nov;120(11):1050-5. doi: 10.1007/s11547-015-0530-4. Epub 2015 Mar 25.
PubMed 25805183Maggio P, Altamura C, Landi D, Migliore S, Lupoi D, Moffa F, Quintiliani L, Vollaro S, Palazzo P, Altavilla R, Pasqualetti P, Errante Y, Quattrocchi CC, Tibuzzi F, Passarelli F, Arpesani R, di Giambattista G, Grasso FR, Luppi G, Vernieri F. Diffusion-weighted lesions after carotid artery stenting are associated with cognitive impairment. J Neurol Sci. 2013 May 15;328(1-2):58-63. doi: 10.1016/j.jns.2013.02.019. Epub 2013 Mar 17.
PubMed 23510565Yun TJ, Sohn CH, Han MH, Yoon BW, Kang HS, Kim JE, Paeng JC, Choi SH, Kim JH, Chang KH. Effect of carotid artery stenting on cerebral blood flow: evaluation of hemodynamic changes using arterial spin labeling. Neuroradiology. 2013 Feb;55(3):271-81. doi: 10.1007/s00234-012-1104-y. Epub 2012 Oct 24.
PubMed 23093072
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Cerebral Microembolisation and Plaque Characteristics After Carotid Revascularization
- ClinicalTrials.gov ID
- NCT03303430
- Acronym / sponsor ID
- PLASTIS
- Conditions
- Carotid Stenosis
- Keywords
- cerebral microembolisation, plaque characteristics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 30 Mar 2019 (estimated)
- Study completion
- 30 Mar 2019 (estimated)
- First posted
- 6 Oct 2017 (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.
Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is recognized as an important outcome measure for carotid revascularization procedures such as carotid stenting (CAS) or carotid endarterectomy (CEA). In fact, cerebral microembolisation occurring during revascularization procedures is associated with an increased risk of peri- and post-procedural stroke, transient ischemic attack as well as neurocognitive decline. Carotid artery stenting is a less invasive alternative to endarterectomy to treat symptomatic or asymptomatic carotid stenosis. Large randomized clinical trials showed a higher periprocedural risk of non-disabling stroke with CAS and a higher periprocedural risk of myocardial infarction, cranial nerve palsy, and access site hematoma with CEA.
However little is known regarding the correlation between the morphological characteristics of the carotid plaque and the occurrence of microembolisation during the procedure and between microembolisation and midterm cognitive impairment. A few studies suggest that plaque morphology may be an important determinant for the increased risk of microembolisation. These studies however have mainly investigated microembolisation occurring during CAS and exploratory studies comparing the two procedures are still lacking.
The purpose of the present study is to determine the correlation between the morphological characteristics of the carotid plaque and cerebral microembolisation either after carotid stenting or after carotid endarterectomy in patients with symptomatic or asymptomatic carotid disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery group | – | Diagnostic Test: MRIThis patient's group will benefit from a endarteriectomy in order to treat their carotid stenosis. |
| Stenting group | – | Diagnostic Test: MRIThis patient's group will benefit from a stenting of their carotid in order to treat their stenosis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Screening of a carotid plaque is part of a routine procedure for patients admitted for stroke or TIA and includes ultrasound, CT-scan and MRI. Patients presenting a symptomatic or asymptomatic carotid stenosis are routinely discussed within a multidisciplinary meeting and the most appropriate therapeutic option is decided. For some patients, surgery and stenting are equivalent options. In that case, the patient may be a candidate for the present study
Key inclusion criteria (2 listed)
- Patients presenting a symptomatic (ipsilateral ischemic stroke, TIA located in the carotid artery territory or retinal ischemia) carotid stenosis between 50% and 99% (according to NASCET and ECST criteria)
- Patients presenting an asymptomatic carotid stenosis between 60% and 99% (according to NASCET and ECST criteria) Patients who accept the informed consent
Key exclusion criteria (10 listed)
- Important neurological deficit with NIHSS >7 (or severe aphasia) at time of inclusion
- Previous known cognitive impairment
- Pregnancy
- Presence of contraindication based on ground of multidisciplinary team decision:
- High bifurcation Intracranial extension of the carotid stenosis Patients with tandem lesions High suspicion of severe siphon stenosis Patients with previous irradiation of the cervical region Patients with restenosis after endarterectomy
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 |
|---|---|---|
| MRIDiffusion weighted imaging 24 hours after revascularisation | Diagnostic test | Stenting group, Surgery group |
Primary outcome
Cerebral microembolisation
Time frame: 24 hours
the presence of at least 1 new hyperintense DWI lesion on the MRI realized within the 24 hours after procedure and will be correlated to the different characteristics of the carotid plaque evaluation.
1 secondary outcome
Neuropsychological assessment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 21536173Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, Duggirala MK, Erwin PJ, Montori VM, Gloviczki P. A systematic review and meta-analysis of the treatments of varicose veins. J Vasc Surg. 2011 May;53(5 Suppl):49S-65S. doi: 10.1016/j.jvs.2011.02.031.
- Background: PubMed 21269847Bonati LH, Fraedrich G; Carotid Stenting Trialists' Collaboration. Age modifies the relative risk of stenting versus endarterectomy for symptomatic carotid stenosis--a pooled analysis of EVA-3S, SPACE and ICSS. Eur J Vasc Endovasc Surg. 2011 Feb;41(2):153-8. doi: 10.1016/j.ejvs.2011.01.001. Epub 2011 Jan 26.
- Background: PubMed 24788967Kernan WN, Ovbiagele B, Black HR, Bravata DM, Chimowitz MI, Ezekowitz MD, Fang MC, Fisher M, Furie KL, Heck DV, Johnston SC, Kasner SE, Kittner SJ, Mitchell PH, Rich MW, Richardson D, Schwamm LH, Wilson JA; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Peripheral Vascular Disease. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Jul;45(7):2160-236. doi: 10.1161/STR.0000000000000024. Epub 2014 May 1.
- Background: PubMed 20189458Bonati LH, Jongen LM, Haller S, Flach HZ, Dobson J, Nederkoorn PJ, Macdonald S, Gaines PA, Waaijer A, Stierli P, Jager HR, Lyrer PA, Kappelle LJ, Wetzel SG, van der Lugt A, Mali WP, Brown MM, van der Worp HB, Engelter ST; ICSS-MRI study group. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol. 2010 Apr;9(4):353-62. doi: 10.1016/S1474-4422(10)70057-0. Epub 2010 Feb 25.
- Background: PubMed 25677309Gensicke H, van der Worp HB, Nederkoorn PJ, Macdonald S, Gaines PA, van der Lugt A, Mali WP, Lyrer PA, Peters N, Featherstone RL, de Borst GJ, Engelter ST, Brown MM, Bonati LH; ICSS-MRI Substudy Investigators. Ischemic brain lesions after carotid artery stenting increase future cerebrovascular risk. J Am Coll Cardiol. 2015 Feb 17;65(6):521-9. doi: 10.1016/j.jacc.2014.11.038.
- Background: PubMed 9437274Rothwell PM, Slattery J, Warlow CP. Clinical and angiographic predictors of stroke and death from carotid endarterectomy: systematic review. BMJ. 1997 Dec 13;315(7122):1571-7. doi: 10.1136/bmj.315.7122.1571.
- Background: PubMed 15277320Biasi GM, Froio A, Diethrich EB, Deleo G, Galimberti S, Mingazzini P, Nicolaides AN, Griffin M, Raithel D, Reid DB, Valsecchi MG. Carotid plaque echolucency increases the risk of stroke in carotid stenting: the Imaging in Carotid Angioplasty and Risk of Stroke (ICAROS) study. Circulation. 2004 Aug 10;110(6):756-62. doi: 10.1161/01.CIR.0000138103.91187.E3. Epub 2004 Jul 26.
- Background: PubMed 25805183Varetto G, Gibello L, Faletti R, Gattuso A, Garneri P, Castagno C, Quaglino S, Rispoli P. Contrast-enhanced ultrasound to predict the risk of microembolization during carotid artery stenting. Radiol Med. 2015 Nov;120(11):1050-5. doi: 10.1007/s11547-015-0530-4. Epub 2015 Mar 25.
- Background: PubMed 23510565Maggio P, Altamura C, Landi D, Migliore S, Lupoi D, Moffa F, Quintiliani L, Vollaro S, Palazzo P, Altavilla R, Pasqualetti P, Errante Y, Quattrocchi CC, Tibuzzi F, Passarelli F, Arpesani R, di Giambattista G, Grasso FR, Luppi G, Vernieri F. Diffusion-weighted lesions after carotid artery stenting are associated with cognitive impairment. J Neurol Sci. 2013 May 15;328(1-2):58-63. doi: 10.1016/j.jns.2013.02.019. Epub 2013 Mar 17.
- Background: PubMed 23093072Yun TJ, Sohn CH, Han MH, Yoon BW, Kang HS, Kim JE, Paeng JC, Choi SH, Kim JH, Chang KH. Effect of carotid artery stenting on cerebral blood flow: evaluation of hemodynamic changes using arterial spin labeling. Neuroradiology. 2013 Feb;55(3):271-81. doi: 10.1007/s00234-012-1104-y. Epub 2012 Oct 24.
- 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.
Loraine Fisch principal investigator
Junior consultant, neurovascular unit
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 Stenosis, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 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 6 Oct 2017. 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 Switzerland. 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 Loraine Fisch (+41795533837, loraine.fisch@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral microembolisation (time frame: 24 hours). 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 NCT03303430, which also lists 10 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 6 Oct 2017.