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Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication.
The type of carotid stent and of cerebral protection are the two most important variables potentially affecting the rate of cerebral microembolization. So far there no consensus on the the best stent and cerebral protection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent Roadsaver® +Filterwire EZ™ | Experimental | The arm assess the efficacy of the combination of the stent Roadsaver® with the Filterwire EZ™ protection |
|
| Stent Roadsaver® + MO.MA Ultra | Experimental | The arm assess the efficacy of the combination of the stent Roadsaver® with the MO.MA Ultra protection |
|
| Carotid Wallstent +MO.MA Ultra | Experimental | The arm assess the efficacy of the combination of the Carotid Wallstent with the MO.MA Ultra protection |
|
| Carotid Wallstent + Filterwire EZ™ | Experimental | The arm assess the efficacy of the combination of the Carotid Wallstent with the Filterwire EZ™ protection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Filterwire EZ™ | Device |
| ||
| MO.MA Ultra |
| Measure | Description | Time Frame |
|---|---|---|
| number of microembolization signals (MES) detected with transcranial doppler | different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device retrieval/deflation | intraprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success | all strokes, major and minor strokes, myocardial infarction | day 2 or day 3 and day 30 complication |
| 6 month clinical follow up | all strokes, major and minor strokes, myocardial infarction |
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Inclusion Criteria:
significant, unilateral carotid artery stenosis with soft plaque defined as:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piero Montorsi, MD | Contact | 0039 0258002 | 576 | piero.montorsi@ccfm.it |
| Stefano Galli, MD | Contact | 0039 02 58002 | 533 | stefano.galli@ccfm.it |
| Name | Affiliation | Role |
|---|---|---|
| Piero Montorsi, MD | Centro Cardiologico Monzino, IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Cardiologico Monzino, IRCCS | Recruiting | Milan | MI | 20138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32007460 | Derived | Montorsi P, Caputi L, Galli S, Ravagnani PM, Teruzzi G, Annoni A, Calligaris G, Fabbiocchi F, Trabattoni D, de Martini S, Grancini L, Pontone G, Andreini D, Troiano S, Restelli D, Bartorelli AL. Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting. JACC Cardiovasc Interv. 2020 Feb 24;13(4):403-414. doi: 10.1016/j.jcin.2019.09.007. Epub 2020 Jan 29. |
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| Device |
|
| Stent Roadsaver® | Device |
|
| Carotid Wallstent | Device |
|
| 6 month |
| Doppler ultrasound assesment | stent patency and long term restenosis of target carotid artery and target vessel external carotid artery | day 2 or day 3, 1 month and 6 month |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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