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

This study has been completed.
Sponsor:
Information provided by:
Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT01274676
First received: January 10, 2011
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Carotid Stenosis
Device: carotid stenting with MOMA
Device: Carotid stenting with filter wire EZ

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Trial of Proximal-versus Distal Cerebral Protection on Micro Embolization During Carotid Artery Stenting in Patients With High Risk Lipid Palque

Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical success [ Time Frame: In hospital and 30 days ] [ Designated as safety issue: Yes ]
    Assesment of any clinical and neurological complication (death, any stroke, TIA; myocardial infarction).


Enrollment: 53
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: carotid stenting with MOMA Device: carotid 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.
Other Name: MOMA device (INVATEC RONCADELLE, BRESCIA - ITALY)
Active Comparator: Carotid stenting with filter wire EZ Device: Carotid 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.
Other Name: Filterwire EZ - Boston Scientific

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-patients with monolateral, significant, soft carotid stenosis

Exclusion Criteria:

  • patients with controlateral carotid occlusion
  • patients with critic stenosis of the external carotid
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274676

Locations
Italy
Centro Cardiologico Monzino, IRCCS
Milan, Italy, 20138
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
Principal Investigator: Piero Montorsi, MD Centro Cardiologico Monzino, IRCCS
  More Information

No publications provided by Centro Cardiologico Monzino

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Piero Montorsi, MD, Centro Cardiologico Monzino, IRCCS
ClinicalTrials.gov Identifier: NCT01274676     History of Changes
Other Study ID Numbers: S111/508
Study First Received: January 10, 2011
Last Updated: January 10, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Centro Cardiologico Monzino:
stenting
carotid plaque
stenosis
angioplasty

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 26, 2014