Carotid Stenting in Patients With High Risk Carotid Stenosis (Soft Plaque)

Randomized Trial of Proximal-versus Distal Cerebral Protection on Micro Embolization During Carotid Artery Stenting in Patients With High Risk Lipid Palque

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01274676

Acronym

MOMA

Enrollment

Registered

2011-01-11

Start date

2009-02-28

Completion date

2010-02-28

Last updated

2011-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Stenosis

Keywords

stenting, carotid plaque, stenosis, angioplasty

Brief summary

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. Thanks to the systematic use of cerebral protection systems, these complications have reduced.A debate concerning which cerebral protective device should be more effective is still ongoing.

Interventions

DEVICEcarotid stenting with MOMA

The MOMA system is an endovascular catheter for proximal protection during carotid stenting. The system allows a concomitant balloon occlusion of both external and common carotid arteries leading to blood flow reversal within the internal carotid artery.

DEVICECarotid stenting with filter wire EZ

The filter wire EZ a distal protection system that is placed in he distal internal carotid artery before carotid stenting. The filter should entrap almost all the debries that are generated during endovascular procedure. At the end of the procedure the filter is retrieved throught a dedicated retrieval catheter.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

-patients with monolateral, significant, soft carotid stenosis

Exclusion criteria

* patients with controlateral carotid occlusion * patients with critic stenosis of the external carotid

Design outcomes

Primary

Measure	Time frame
number of Microembolization signals (MES) detected with transcranal doppler	6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation

Secondary

Measure	Time frame	Description
Clinical success	In hospital and 30 days	Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026