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OpenTrials
Completed

NCT Number: NCT01274676

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

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.

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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Constriction, Pathologic Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Cardiologico Monzino, IRCCS

Milan, 20138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-patients with monolateral, significant, soft carotid stenosis

Exclusion criteria

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

Treatment and study plan

carotid stenting with MOMA

Device

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.

Other names: MOMA device (INVATEC RONCADELLE, BRESCIA - ITALY)

Carotid stenting with filter wire EZ

Device

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.

Other names: Filterwire EZ - Boston Scientific

Primary outcomes

  1. number of Microembolization signals (MES) detected with transcranal doppler

    Time frame: 6 different phases of carotid stenting (lesion wiring; predilation; stent crossing of the lesion; stent deployment; stent post dilation; device tetruieval/deflation

Secondary outcomes

  1. Clinical success

    Time frame: In hospital and 30 days

    Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Registry information

Official study title

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

Acronym: MOMA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 11, 2011
Registry last updated
Jan 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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